Avandia Continues to Face Scrutiny: Biotech's Latest Mishaps

GlaxoSmithKline’s (GSK) diabetes drug Avandia is once again under regulatory scrutiny—this time it’s in Europe where the European Medicines Agency met to discuss whether Avandia should continue to be marketed. The agency in a press statement said that no final decision has been made about the drug.

It said it has further questions for GSK before deciding whether and what action needs to be taken. A final decision is expected by September 23. The meeting took place as a controversy erupted in the United Kingdom over a recommendation made at the end of July by the UK Commission on Human Medicines, according to TheHeart.Org. The commission unanimously voted that Avandia should be withdrawn. Though it informed the Medicines and Healthcare Products Regulatory Agency, the agency responsible for licensing drugs in the United Kingdom, its decision was not made public. Instead the agency sent letters to doctors restating safety information about the drug and suggesting they consider alternatives. Because the drug was approved by the European Medicines Agency, only it can revoke the license for the drug.

Roche said it halted dosing of patients in a late-stage trial of its experimental diabetes drug taspoglutide because side effects including nausea and vomiting resulted in many participants in the study to drop out of it, Bloomberg reported. The company is trying to determine what caused the side effects and see if it can reformulate the medication to reduce the risk, a spokeswoman told Bloomberg. Because a large number of patients dropped out of the study, the company said it would be difficult to determine whether the drug is effective.

Genzyme is laying off an undisclosed number of staff as part of a restructuring first announced in May, Reuters reported. The company said the move was unrelated to Sanofi-Aventis’ efforts to acquire the company. Genzyme has 12,800 employees. It offered no estimates on how much it expects to save through the restructuring.

Shares of Idenix Pharmaceuticals (IDIX) plummeted after the U.S. Food and Drug Administration ordered the company to halt a mid-stage study of two experimental hepatitis C drugs. Three healthy volunteers testing a combination of the drugs IDX184 and IDX320 showed elevated liver enzyme levels in a routine post-study safety test, the Cambridge, Massachusetts company says. Although liver function returned to nearly normal levels in all three subjects, the FDA placed a clinical hold on the study until it can discuss the results and other relevant data with Idenix. Idenix shares fell to $3.18 from $5.99 on the day it was announced. On top of that punishment, the hold will also likely make Idenix's ongoing search for an outside partner to advance its hepatitis C program more difficult. [see story].

U.S.-based Valeant Pharmaceuticals International and Canada’s Biovail plan to eliminate about 25 percent of their combined workforce once a merger is completed between the two companies, Reuters reported. The company’s said they expect to save more than $300 million through cost synergies with more than $200 million being realized in 2011. The companies have a combined workforce of about 4,400.

Marc Tessier-Lavigne, Genentech’s (DNA) executive vice president of research and chief scientific officer, is leaving the biotech to become president of Rockefeller University in New York, Reuters reported. The departure of Tessier-Lavigne, the second highest executive in research at Genentech, is one of the most significant executive changes since Roche acquired Genentech last year. He takes on his new post in early 2011.

U.S. Food and Drug Administration is requiring that certain contrast agents used in magnetic resonance imaging carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis, if the drug is administered to certain patients with kidney disease.

Nephrogenic systemic fibrosis or NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may lead to death, especially if it involves body organs. The order pertains to gadolinium-based contrast agents or GBCAs.

The agency said three of the GBCAs—Magnevist, Omniscan, and Optimark— will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration.

GBCAs are intravenous drugs used to help detect abnormalities of body organs, blood vessels, and other tissues through MRI. Magnevist is marketed by Bayer Healthcare, Omniscan by GE Healthcare, and Optimark by Covidien (COV).

read more» Read more...

Dapagliflozin is a new drug for the treatment of type two diabetes

A strange drug, the premier in its class, gives added blood sugar dominate to mobile vulgus with category 2 diabetes who are already enchanting the glucose-lowering medication metformin.

The budding agent, dapagliflozin, which also helped patients squander weight, is novel in that it does not produce directly on the body’s insulin mechanisms, according to a inspect appearing in the June 26 issue of The Lancet and slated for conferral at the annual gathering of the American Diabetes Association (ADA) in Orlando Noroxin. “It will likely be used as an add-on therapy,” said swotting lead author Clifford Bailey, a chemical pathologist and professor of clinical study at Aston University in Birmingham, UK “If you don’t unreservedly get to quarry with the maiden therapy tried , this approach would put on the market you an opportunity hopefully to maintain improved control”.

Bailey, who could not vaticinate if or when the drug might get final approval from cure-all regulatory authorities, also pointed out that dapagliflozin is flexible, message it can be used with various other treatments and at more or less any stage in the disease. “It’s a seemly add-on,” agreed Dr Stanley Mirsky, accomplice clinical professor of metabolic diseases at Mount Sinai Medical Center in New York City buy Tramaden. “is it a ask oneself drug? no. It may room a insufficient role”.

The con was funded by Bristol-Myers Squibb and AstraZeneca, which are developing dapagliflozin together. Dapagliflozin machinery by inspirational the kidneys to annihilate more glucose from the body via urine Actos. In this scrutiny of 534 adult patients with type 2 diabetes who were already irresistible metformin, the highest dispense of dapagliflozin (10 milligrams daily) was associated with a 0,84 percent diminish in HbA1c levels.

HbA1c is a compute of blood sugar control over time. Participants alluring 5 mg of the dope saw a 0,70 percent decrease in HbA1c levels, while those delightful 2.5 mg had a 0,67 percent decrease. In the placebo group, the subsidence in HbA1c was 0,3 percent, the haunt found.

Weight injury was also greater in volunteers winsome the study drug: 2,2 kilograms (4,8 pounds) in the 2,5 mg group; 3 kilograms (6,6 pounds) in the 5 mg group; and 2,9 kilograms (6,4 pounds) in the 10 mg group. Those in the placebo bunch misplaced 0,9 kilograms, or almost 2 pounds. Much, though not all, of this damage was like as not to be tap water weight, the authors stated.

There were more genital infections seen among those attractive dapagliflozin, the pair noted. “One of the complications of the poison is an enlargement in urinary tract infections or yeast infections because you have grave glucose levels in the urine,” said Dr Jacob Warman, boss of endocrinology at The Brooklyn Hospital Center in New York City. “That’s a very eulogistic way of life usual for yeast, so the endocrinologists aren’t too ecstatic about that”.

On the other hand, he said, this drug appears to run without some of the kidney, liver and muscle complications of other drugs so “it would be the best as an add-on to usual medications”. A assign study, also simultaneously being presented at the ADA encounter and published in The Lancet, found that adding inhaled insulin before each luncheon and long-acting insulin glargine before prevailing to bed worked just as well as engaging conventional therapy.

The regular psychotherapy consisted of taking biaspart insulin twice a day. This is a combine of short-acting insulin and intermediate-acting insulin. The altered regimen tangled less weight gain, fewer episodes of inadequate blood sugar and was more convenient, according to the study, which was funded by MannKind, the maker of Technosphere, the inhaled insulin featured in the trial.

A third burn the midnight oil found that once-weekly injections of the treatment Byetta (exenatide) worked better at controlling blood sugar levels than long-acting insulin. The training thus far has been to give Byetta twice a day. This study, funded by Amylin Pharmaceueticals and Eli Lilly, looked at a supplementary formulation of the drug buy generic sildenafil. Patients who got the once-a-week tone also perplexed an middling of 2,6 kilograms (5,7 pounds), the read found.

read more» Read more...

FDA Approves Orphan Drug Status for Type 1 Diabetes Stem Cell Therapy

The US Food and Drug Administration (FDA) has approved orphan drug designation for a stem cell therapy in patients with newly diagnosed type 1 diabetes mellitus.

The product is an intravenous formulation of adult mesenchymal stem cells (MSCs) that are isolated from the bone marrow of healthy young adult donors, thereby avoiding the controversy associated with embryonic and fetal cell sources. Cell culture allows the large-scale production of thousands of doses from a single donation.

According to a company news release, MSCs are designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation. Preclinical studies indicate that MSCs may delay the progression of type 1 diabetes by preserving beta cell function.

Treatment safety and efficacy are currently being evaluated in a 62-patient, double-blind, placebo-controlled phase 2 study conducted at 20 medical centers across the United States. To be eligible, patients must be aged 12 to 35 years and have been diagnosed 2 to 20 weeks before study entry.

The MSC therapy previously was granted FDA orphan drug status and expanded access approval for graft vs host disease, allowing its use in patients whose condition is life-threatening.

Other potential indications under investigation include Crohn's disease, myocardial infarction, and pulmonary disease.

read more» Read more...

Diabetes Drug Metformin May Reduce Risk of Breast Cancer

Metformin, a medication commonly used in the treatment of type 2 diabetes, may reduce the risk of breast cancer when used for more than five years, according to a new study published by the American Diabetes Association. The study adds fuel to increasing evidence of metformin's potential anti-cancer effects.

The study, led by Dr. Christoph R. Meier of Switzerland, followed more than 1,000 women in the U.K. using the drug to treat diabetes. Women using metformin for more than five years were at a 56 percent lower risk of breast cancer than those who never took the drug.

The study was relatively small, and while a direct cause and effect link between the drug and the reduced risk has not been established, researchers believe the connection may be related to metformin's actions on a key metabolic enzyme known as AMP-activated protein kinase as well as its insulin-reducing activity.

The study comes just days after researchers at the American Association for Cancer Research presented findings suggesting metformin may lower the risk of lung cancer in smokers.

During its 15 years in use, metformin has become a popular drug for the treatment type 2 diabetes, a condition in which insulin does not properly carry sugar out of the bloodstream and into cells. Metformin helps regulate blood sugar levels and prevent complications in patients with the disease by reducing the amount of glucose absorbed in the stomach and produced in the liver while also enhancing the performance of insulin.

As the evidence for metformin's anti-cancer effects rises, additional studies addressing the medication's potential in cancer reduction are in the works.

Additional information about drugs and drug side effects may be found on Drugwatch.com.

read more» Read more...

Novo's Victoza beats Merck drug in diabetes study

Novo Nordisk's new diabetes drug Victoza proved more effective than Merck & Co's Januvia in a head-to-head study, boosting prospects for a product that has got off to a strong start in key markets.

Daily injections of both high- and low-dose Victoza reduced blood sugar levels by more than a daily tablet of Januvia in people with type 2 diabetes who had not responded adequately to the older drug metformin, researchers said on Friday.

The results may help the Danish drugmaker, which funded the study published in the Lancet journal, to differentiate its medicine in a highly competitive marketplace.

Victoza is Novo's biggest new drug hope and is expected to generate annual sales of more than $1.4 billion by 2014, according to consensus forecasts compiled by Thomson Reuters.

After a delayed path to market, prescription trends suggest it is now doing well in both Europe and the United States, in contrast to disappointing sales of some other recently launched new drugs, such as Eli Lilly's bloodthinner Effient.

Mads Krogsgaard Thomsen, Novo's chief scientific officer, said the results followed other positive comparative studies and would bolster Victoza's reputation among medical experts.

"The fact that Novo Nordisk has now done most, if not all, of the major comparator studies against different classes of oral and injectable anti-diabetic drugs really shows our commitment to showing comparative efficacy in a serious way," he said in a telephone interview.

Novo demonstrated two years ago that Victoza controlled blood sugar better than Byetta, a drug from the same class of medicine that is sold by Eli Lilly and Amylin Pharmaceuticals.

Progress Report

With investors awaiting a progress report on Victoza's sales prospects when Novo reports first-quarter results on April 27, Thomsen said demand for the new drug was following the company's own "optimistic" expectations.

"We have overtaken Byetta in several European markets in the first nine months post launch and in the U.S. we are already seeing, nine weeks into the launch, a rather sizeable uptake," he said.

In the latest study, 1.8 milligrams of Victoza, or liraglutide, lowered levels of HbA1c -- a standard blood measure that is indicative of a patient's glucose levels -- by 1.5 percentage points against 0.9 percent for Januvia, or sitagliptin.

The lower dose of 1.2 mg of Victoza cut HbA1C by 1.2 points in the six-month trial.

Researcher Dr Richard Pratley of the University of Vermont College of Medicine and colleagues said the difference was "clinically relevant," adding that patients on Victoza, which caused some nausea, also lost more weight.

In an accompanying comment, Dr Andre Scheen and Dr Regis Radermecker of Belgium's University of Liege said 1.2 mg of Victoza should be considered as a starting dose in most cases, with patients moving up to 1.8 mg if necessary.

On the downside, they noted that Januvia was cheaper, caused fewer gastrointestinal upsets and "one pill of sitagliptin daily might be judged as easier to administer than one subcutaneous injection of liraglutide daily."

read more» Read more...

A New Way to Inhale, Not Inject, Insulin

People with diabetes often inject themselves with insulin at mealtime to help control their blood sugar levels. But a new, palm-size device may let them discretely inhale a dose of insulin instead of using a needle.

A small inhaler and insulin powder created by the MannKind Corporation, a drug developer in Valencia, Calif., are before the Food and Drug Administration for marketing approval.

The insulin powder, called Afresa, is inhaled into the lungs, dissolves there and then travels into the bloodstream, says Matthew J. Pfeffer, chief financial officer at MannKind.

Using insulin or other drugs to control blood sugar helps diabetics avoid serious complications, including heart disease, kidney failure, blindness and nerve damage.

The use of insulin in an inhaled form is not new. It was introduced by Pfizer with a product called Exubera in 2006. But the inhaler used with Exubera was large and awkward, some critics contended, which may have been a reason the product didn’t become popular. It was withdrawn less than two years after federal approval.

But MannKind may have better prospects because of its smaller inhaler and fast-acting insulin. Mr. Pfeffer says the MannKind inhaler fits neatly in one hand, and a second-generation versions the company is using in clinical trials is even smaller, the size of a whistle.

Patients put insulin doses — pre-packaged in cartridges — into the inhaler and turn the mouthpiece to release the insulin. The inhaler uses no electricity or compressed gas. “The patient’s breathing action does the job,” Mr. Pfeffer said. “The airflow through the cartridge allows the powder to be inhaled.”

The system now before the F.D.A. is for adults with Type 1 diabetes, which often begins in childhood, and Type 2 diabetes, which typically occurs when people are older.

Simos Simeonidis, a senior biotechnology analyst at the New York investment bank Rodman & Renshaw, who wrote a report on MannKind, said he expected its system to be available next year, if the F.D.A. approved. (Dr. Simeonidis has no stock in MannKind, but Rodman & Renshaw has provided investment banking services for it.)

Leonid Poretsky, chief of endocrinology at Beth Israel Medical Center in New York and director of the Gerald J. Friedman Diabetes Institute there, said that the MannKind system will face many problems even if it is approved.

“Injections today are essentially painless,” he said of the short, thin needles that are commonly used to inject insulin. And you don’t necesssarily “have to draw from a bottle into a syringe. Injections work so well that the advantages of a new route like this are unclear.”

Dr. Poretsky was also concerned about using the lungs to transport drugs. “It’s possible for people to stay on insulin for decades,” he said. “The whole issue of exposing the lungs to insulin for a long period of time has to be examined carefully.”

Dr. Gerald Bernstein, a New York-based endocrinologist who is a former president of the American Diabetes Association, agreed that the long-term use of inhalable insulin might carry risks for some patients. Dr Bernstein is vice president of the Generex Biotechnology Corporation, which is developing an insulin delivered through the lining of the mouth.

“It’s counterintuitive to use the fragile cells of the alveoli,” the tiny air sacs within the lungs, “to get insulin to the bloodstream,” he said. “The lungs were developed to transport gases, not proteins.”

Mr. Pfeffer of MannKind said that the company’s clinical data included no signs of damage to lungs.

Dr. David M. Nathan , a professor of medicine at Harvard Medical School and director of the Massachusetts General Hospital Diabetes Center, said that even if safety issues were addressed, there could be other long-term problems with Afresa. He questioned whether MannKind’s inhalable product could achieve the same level of blood sugar control as that obtained with injections or insulin pumps.

“Insulin inhalers are tricky to use,” he said. “The amount you breathe in can be variable.” But he acknowledged that injections aren’t perfect and that many people would prefer to get their insulin in a more convenient way.

Mr. Pfeffer said trials by MannKind had shown a high consistency in doses by patients using the inhalers.

If all goes well at the F.D.A., Mr. Pfeffer says he thinks that MannKind will eventually go to market with the smaller dispenser now in trials. “The expectation,” he said, “is that we will launch with the whistle-sized inhaler” — which, by the way, was given the internal company name “Dreamboat” by its design team.

“Perhaps we’ll consider a different name, though,” he said.

read more» Read more...

New obesity drug fights diabetes

A newly developed medication can help not only reduce weight but also effectively reverse diabetes and lower the cholesterol level in mice.

According to a study published in Chemistry and Biology, fatostatin interferes with a range of some 63 genes, many of which are switched on by overeating.

The new drug influences the sterol regulatory element binding proteins (SREBPs), activating the genes involved in making cholesterol and fatty acids.

"Fatostatin blocked increases in body weight, blood glucose, and hepatic (liver) fat accumulation in (genetically) obese mice, even under uncontrolled food intake," the researchers wrote.

The drug was also reported to be effective in fighting prostate cancer, indicating the link between prostate cancer and obesity.

Researchers, therefore, concluded that fatostatin is a 'master controller' switch which can cut off fat-making genes in mice.

They, however, doubt whether the drug would result in similar effects in humans.

Scientists hope their findings will lead to the development of a medication to could simultaneously fight obesity and other obesity-related health problems such as cancer, heart disease and type 2 diabetes.

Source : www.presstv.ir

read more» Read more...

New drug may put brakes on diabetes

As many as 3 million Americans are living with Type 1 diabetes. Doctors say having a sibling or parent with the condition increases your risk of developing it and managing it can mean four or more injections a day or wearing an insulin pump.

But what if you could stop diabetes in the early stages before you need all of those needles? That's the goal behind a new experimental treatment. One teen is gambling on a drug in hopes of putting the brakes on his diabetes.

Seventeen-year-old Daniel Albright has Type 1 diabetes. He is 1 of 3 kids in the Albright family with it.

Since his siblings were diagnosed first, Daniel was monitored and doctors spotted signs of his diabetes early. Right now he's in a honeymoon period -- his body's still producing some insulin.

"We wanted to see what we can do to prevent it from getting worse, to stop it in it's tracks," said Donna Albright, Daniel's mom.

Daniel enrolled in a clinical trail to put the brakes on his diabetes. He gets monthly infusions of a rheumatoid arthritis drug called, Abatacept. The goal is to stop Daniel's immune system from killing the insulin-producing cells he has left.

"When you're first diagnosed with diabetes you probably have anywhere from 10 to 30 percent of your insulin producing cells still available and we'd like to freeze it there," said Dr. William Russell from Vanderbilt University.

In animals, the drug prevented full-blown diabetes from developing. In people, that would mean lower doses of insulin, easier blood sugar control and a lower risk of hypoglycemia, or dangerously low blood sugar.

"It's much easier to take care of diabetes when the patient themselves is making adequate amounts of insulin," said Dr. Russell.

After a couple of months of infusions, Daniel uses less insulin than his siblings, and doesn't need a pump.

Source : abclocal.go.com

read more» Read more...

What Will Save You from Diabetes

Diabetes is a silent disease. If it goes undetected, it can become a life threatening disease. People have been known to have their legs amputated due to diabetes. Why is this so? It is simply due to the fact that people are not able to identify the possible diabetic symptoms. Just try asking some people about diabetes and you will be surprised with the answer.

I know because my aunt was one such casualty of diabetes. You see, she was diabetic but did not know about it. Not realizing that she was diabetic, she continued eating whatever she liked. There was no diet because of her ignorance. When she developed a sore in her right leg, not knowing that a diabetic had to take additional care where wounds or injuries are concerned, she ignored it as she thought it would heal itself. After all it was just a small sore. It did not go away, and instead, the sore in her leg became a bigger wound. It was later that she decided to visit a doctor. However, it was too late as the wound developed into gangrene. She had to have her leg amputated. Though this happened in the late 1970's, today in the 21st century, people are still as ignorant of diabetes as in the 1970s.

In most developed countries as well as in the third world countries, access to medical doctors are easier than in the 1970s. So there is no excuse whatsoever to be ignorant about this life-threatening disease. Also, there is always the library that a person can turn to for information on diabetes. If you are still unable to obtain the correct information on diabetes, then turn to the Internet to seek for more information. There are a number of websites on diabetes, ranging from diet to controlling diabetes. There is absolutely no excuse not to be well informed about diabetes.

You may ask why am I so concerned about diabetes? Let's put it this way, ought not we be concerned about a silent killer? There has been a lot of publicity on other diseases such as cancer. But there is not much publicity on diabetes. Yes, I did say that there are a number of ways to obtain information on diabetes, but the publicity to make people more aware of diabetes is sadly insufficient. I believed that there should be more publicity to reach out to a larger crowd of people to educate them on the dangers of diabetes.

The problem with diabetes is that living in this modern world, we are bombarded with advertisement on the different types of food and beverages made available to us. As we consumed these processed food and beverages, guess what happened next? Our body system starts to react to the food and beverages. In processed food and beverages, manufacturers being concerned with the bottom line, will continue to add more refined sugar and salt to make the food and beverages tastier. Imagine, when someone kept on consuming all these stuff, especially if it is full of sugar! What will happen next? Our body will start to fail us. It would not be able to make use of the excess sugar and these will just be in our blood. I'm not talking only about the refined sugar. Almost at fault are food items such as refined rice and potatoes that will make our blood sugar rise faster and if not taken care of, will possibly result in diabetes.

The previous paragraph talks about food and beverage laden with sugar and refined carbohydrates. But there is another aspect to this. As we progressed as a modern society, we have lesser time for exercise. Of course, there will be some amongst us who are disciplined to continue with their exercise routine. This is not so for the majority of us. What will happen? Simply this, with the consumption of all those refined food and beverages, coupled with a lack of exercise, we will see more and more people suffering from diabetes. What makes it scary is that most will not be aware that diabetes is within striking distance of them.

So what is it that we, as individuals can do about it? I will list out a couple of steps here. In future, more will be outlined. Firstly, we need to find out our own genetic history. Trace back to your parents and grandparents. Check whether any of them had histories of diabetes. If no, then the chance of getting diabetes is reduced. I say only reduced because there is no guarantee that diabetes will not strike at a later stage. For those of you who are able to trace back your family history and discover that one of your parents or grandparents had diabetes, your chance of getting diabetes is increased. However, this is not the end of the world. There are many ways and means to avoid or delay the onset of diabetes.

by: Tom Yancy Cove
Source : www.articlecity.com

read more» Read more...

FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

Source : www.fda.gov

read more» Read more...

How to Cure Type 2 Diabetes - A Simple Plan of Exercise and Dieting

How to cure type 2 diabetes is a question on about 1 in 3 Americans' minds. Can you believe that so many people are diabetic or pre-diabetic?
Yet, the American Diabetic Association (ADA) still states that there is no cure for diabetes. And even yet, thousands of people will cure diabetes this year. Who is telling the truth? In this article, you will learn the basics of how to cure type 2 diabetes with exercise and dieting.

Why Curing Diabetes Works

Have you seen the popular show, The Biggest Loser? Recently, one of the overweight contestants lost pounds of fat and changed her life. I was impressed to hear how she naturally cured her high blood pressure and cured her diabetes in a matter of 10 weeks.

How did she do it? Exercise and dieting.

And research study after research study shows that the best way to become healthier and cure common diseases like gout, high blood pressure, and diabetes is good old fashion exercise and dieting. Here are some tips to help you make your diet simpler, your exercise program simpler and cure type 2 diabetes.

Cure Type 2 Diabetes Naturally

Simpler is better. These tips may be considered simple but they will reverse diabetes in a matter of weeks. Just try them!

1. Drinking water should be an important habit throughout the day. Water can help you lose weight and also keep your body flushed. It also makes healthier cells which will eventually accept insulin. You should drink at least 2 cups of water for every 2 hours you are awake. Do the math and make a goal today.

2. Avoid sugar and avoiding carbohydrates is extremely important to start your diet. Sugar is obviously a no-no for diabetics. Carbohydrates and starches are also important to avoid because they are converted to glucose once it mixes with saliva. In other words, carbohydrates are like eating tablespoons of sugar.

Once you reverse or cure diabetes, you will be able to reintroduce carbohydrates to your body through whole grains.

You should avoid breads, pastas, cereals, crackers, potatoes and chips for a few weeks while your blood sugar normalizes.

3. Exercising is also important for making new cells that accept insulin and normalizing blood sugar. Try to exercise once a day for at least 30 minutes (you can go longer). Exercising has been shown to help in the cure of diabetes.

Exercise is beneficial because it will reduce insulin resistance, ward off diabetes complications, help you lose weight, make you feel and look better and help you maintain a steady blood sugar level for life.

If you live an inactive lifestyle, start by exercising only a little each day. Gradually work your way up to exercising more which will reduce the chance of burning out. And find something you enjoy like biking, hiking or swimming.

Cure Diabetes in 4 Weeks

Your body creates about 60,000 new cells by the time it takes you to read one sentence. Imagine if your body was healthy enough to create cells that accept insulin and start reversing diabetes. Imagine curing diabetes in 4 weeks with a 100% guaranteed, step by step plan.

Cure Type 2 Diabetes

Guaranteed! Researched! Step by step! Joe Barton challenges you to learn how to cure type 2 diabetes in 4 weeks.

by : Joe Barton
Source : www.amazines.com

read more» Read more...

Two-year data show investigational drug liraglutide more effective at lowering blood sugar than glimepiride

Data presented today at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily liraglutide, taken as monotherapy, leads to statistically significant and sustained reductions in blood sugar and weight after two years of treatment.

In the study, 58% of patients treated with liraglutide 1.8 mg once daily reached and maintained the ADA’s blood sugar target of HbA1C less than 7% versus 37% of patients treated with glimepiride 8 mg once daily.

“The fact that liraglutide continues to effectively lower blood sugar after two years of treatment is consistent with its other long-term clinical benefits such as continued reductions in fasting blood sugar and weight,” said Dr Alan Garber, Baylor College of Medicine, Houston, a LEAD™ 3 principal study investigator. “Even with available treatments, many type 2 diabetes patients still struggle to control their blood sugar, while losing weight. Liraglutide represents an important advance for these patients.”

The LEAD™ 3 extension study also documented that treatment with liraglutide leads to early and lasting weight loss. Many currently available diabetes treatments lead to weight gain(2), a concern for type 2 diabetes patients, most of whom are already overweight.(3) After two years of treatment with 1.8 mg of liraglutide, mean body weight decreased significantly (-2.7 kg) compared to overall weight increase in the glimepiride group (+1.1 kg).

Hypoglycaemia is a condition where blood sugar levels become too low. Minor hypoglycaemia was more than six times less frequent in the liraglutide treatment groups compared with the glimepiride group.

For more details : Visit This

read more» Read more...

Glaxo's GLP-1 diabetes drug beats Byetta in test

An experimental diabetes drug from GlaxoSmithKline was more effective than Eli Lilly and Amylin Pharmaceuticals' Byetta in controlling blood sugar, a mid-stage test unveiled on Sunday.

Glaxo's injectable Syncria belongs to the same class of medicines, called GLP-1s, as Byetta and Novo Nordisk's Victoza, which the Danish drugmaker expects to launch in Europe this summer.

Safety issues have recently clouded prospects for the GLP-1 drug class.

In a 356-patient Phase II clinical study, presented at the annual meeting of the American Diabetes Association, Glaxo's Syncria, given once weekly, reduced HbA1C -- a common measure of blood sugar -- by 0.9 percent compared to 0.5 percent for Byetta, which is injected twice daily.

Syncria also caused patients to lose 0.9-1.8 kilos in weight, depending on dose. Common side effects included nausea, vomiting and headache.

British-based Glaxo began a final-stage Phase III clinical programme for the new medicine at the beginning of 2009, which is expected to take two to three years to complete.

GLP-1s have been touted as potential multibillion-dollar sellers, given demand for new ways to fight a global epidemic of type two diabetes driven by rising obesity levels.

But recently doubts have grown about the drug class, after Novo's Victoza caused thyroid cancer in rats and there were cases of pancreas inflammation last year with Byetta.

In case of Syncria, Glaxo's vice president of clinical development Murray Stewart said the drug could not be tested on rats for technical reasons but ongoing studies using monkeys had shown no signs of thyroid problems.

He remains optimistic that GLP-1s will emerge as an important new treatment option for difficult-to-treat diabetics, since they are highly effective at controlling blood sugar levels and also help people lose weight.

Some analysts have predicted they will lose out to DPP-4 inhibitors, another novel type of treatment for diabetes.

"I think in four years time people will realise there is probably no risk with pancreatitis and the thyroid issue is more related to animals than it is to humans," Stewart said.

"There is scientific reason to believe these issues will not be real and the benefits of the GLPs compared to the DPP-4s will be demonstrated."

Source : www.reuters.com

read more» Read more...

Stents no better than heart drugs in diabetics

Diabetics with stable heart disease do just as well taking drugs alone as getting quick angioplasty or bypass surgery to open blocked heart arteries, U.S. researchers said on Sunday.

They said patients advised to have angioplasty and a heart stent to restore blood flow and ease chest pain could safely wait and give drugs a chance to work.

But those with more severe disease sent for more invasive heart bypass surgery might be able to avoid a future heart attack if they have the surgery right away.

The study also found no difference in heart risks between two strategies for treating type 2 diabetes -- increasing the amount of insulin or lowering the body's resistance to its own insulin with drugs such as either metformin or GlaxoSmithKline's Avandia, also known as rosiglitazone, which had been thought to raise the risk of heart attacks.

"If you have diabetes and heart disease such that a bypass surgery is a recommended procedure, you should have that early rather than delaying it," said Dr. Trevor Orchard of the University of Pittsburgh, whose study appears in the New England Journal of Medicine.

Orchard said the study, also being presented at the American Diabetes Association meeting in New Orleans, offers evidence on how best to treat people with both type 2 diabetes and heart disease. More than 65 percent of people with diabetes die from heart disease or stroke.

For GlaxoSmithKline, the study represents a positive sign that Avandia may be safer than earlier analyses had suggested.

But it may be another blow for stent makers such as Boston Scientific Corp and Johnson & Johnson , whose U.S. sales plummeted after a similar study two years ago showed stents were no better than drugs at preventing death and heart attacks in all types of heart patients.

Stents are wire mesh tubes that prop open diseased arteries after they have been unclogged during angioplasty.

Questioning Angioplasty

In a commentary in the journal, Dr. William Boden of the University at Buffalo in New York said doctors should question why so many diabetics still get angioplasty.

"The continued high rate of use of (angioplasty) (1.24 million procedures per year in the U.S.) and the high rate of drug-eluting stent usage strongly suggests that we critically reassess our approach to revascularization, if needed, in diabetics with coronary disease," Boden wrote.

Diabetics with stable chest pain account for about 40 percent of all U.S. patients who get angioplasty, according to Wachovia analyst Larry Biegelsen, who said the findings could cut U.S. procedures by 3 percent.

The study involved 2,368 patients who either got treated right away with angioplasty, usually with a stent, and drugs or simply got drug treatment. It found no difference in the rates of death, heart attack or stroke after five years.

The study also looked at the risks and benefits of two strategies for controlling blood sugar in patients with type 2 diabetes, in which people lose the ability to use insulin.

One group took insulin injections or drugs known as sulfonylureas that boost the body's production of insulin. The other took insulin-sensitizing drugs like metformin or drugs known as glitazones, which include Avandia or Takeda Pharmaceutical Co's (4502.T) pioglitazone, brand name Actos.

Orchard said about 60 percent of patients in the insulin-sensitizing group took rosiglitazone or Avandia. He said there was no increased risk of heart attacks among patients in this group.

Source : www.reuters.com

read more» Read more...

Avandia Study Spurs New Heart Risk Debate

A company-sponsored clinical trial shows that the diabetes drug Avandia causes no more heart deaths than standard treatment, but critics say the study is flawed.

Avandia, made by GlaxoSmithKline, is an oral drug that makes the body more sensitive to insulin.

But concerns that Avandia causes heart problems has led the American Diabetes Association's treatment guidelines committee to advise against prescribing Avandia in favor of Actos, another drug in the same class with fewer heart-safety concerns -- although both drugs increase a patient's risk of heart failure.

GlaxoSmithKline's RECORD study was supposed to answer these concerns. And according to study leader Philip D. Home, DPhil, of the U.K.'s Newcastle University, it did. Home presented the study findings at this week's meeting of the American Diabetes Association in New Orleans.

"The findings are essentially that in overall cardiovascular terms the drug is safe," Home said at a news conference. "There is no increased or decreased risk of death from heart disease, and that includes the heart failure data."

David Nathan, MD, chairman of the American Diabetes Association guideline committee, said the group would reconsider its recommendations in light of the study findings.

However, the study was unable to determine whether Avandia increases a patient's risk of heart attack. That concern was raised by several experts, including Steven Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen remains unconvinced by the final report from Home and colleagues.

"The RECORD trial is seriously flawed," Nissen tells WebMD. "The authors don't reveal the number of patients who were still taking Avandia by the end of the study, but I would estimate this number to approach 50%. Obviously, it is impossible to assess the safety of a drug when patients are not actually taking it."

Home says patients assigned to Avandia treatment took the drug for 88% of the study time. But Nissen says Home's own previously published interim findings do not support this calculation.

Indeed, Home agrees that the study does not answer the question of whether patients taking Avandia have an increased risk of heart attack.

"But what we do know is that this is not associated with cardiovascular death," he said. "There were actually fewer deaths in the [Avandia] group."

In the study, all patients received standard treatment with metformin and/or a sulfonylurea. Half added Avandia to this treatment. The study was not blinded, meaning that study investigators and patients knew which treatment they were getting.

Nissen doubts that this unblinded study will convince experts to change their minds about Avandia. That, he says, will happen only if a new study -- the just-started TIDE study -- shows Avandia is truly safe. The TIDE study is a double-blind trial. And even though it is sponsored by GlaxoSmithKline, there will be a direct comparison of Avandia to Actos, made by Takeda Pharmaceuticals.

Home disagrees, and expects the American Diabetes Association committee to give serious consideration to the new findings, which appear in the June 5 early online edition of The Lancet.

In an editorial accompanying the study, Ravi Retnakaran and Bernard Zinman of Toronto's Mt. Sinai Hospital agree with Nissen that the study's open-label design -- and it's much lower-than-expected rate of cardiovascular deaths -- are problematic.

"Definitive conclusions about the relation between [Avandia] and cardiovascular risk remain elusive, owing to study limitations," Retnakaran and Zinman write. "Furthermore, the findings are inconclusive for [heart attack], for which a non-statistically-significant increased risk was noted in the [Avandia] group."

Unfortunately, a definitive answer isn't soon forthcoming. The TIDE trial isn't scheduled to end until October 2015.

Meanwhile, Retnakaran and Zinman suggest that doctors consider prescribing half doses of Avandia, noting that a half dose offers more than half the benefit of a full dose -- and fewer risks.

Source : diabetes.webmd.com

read more» Read more...

Diabetes Drug Makes Vaccines Work Better

The diabetes drug metformin may make vaccines work better, exciting new studies suggest.

"These findings were unanticipated, but are potentially extremely important and could revolutionize current strategies for both therapeutic and [preventive] vaccines," University of Pennsylvania researcher Yongwon Choi, PhD, says in a news release.

Choi's team wasn't initially interested in diabetes drugs -- and wasn't trying to improve immunizations.

The scientists were trying to figure out how the immune system remembers disease-causing agents so that it can mount a rapid immune response the next time it sees that agent.

This so-called immune memory depends on cells called memory T cells that lurk in the body, becoming active only in the presence of the pathogen they're programmed to recognize.

During an infection -- or after an immunization -- the body mounts a massive T-cell response to fight off the invasion. These T cells go away after the threat is neutralized, but a few of them survive to become memory T cells. How this happens has been a mystery.

Choi's team found that memory T cells survive by switching their fuel supply. Instead of burning glucose, as most cells do, they start burning fat. The researchers bred a strain of mice that lacked the ability to switch fuel sources, and these mice could no longer make memory T cells.

One of metformin's effects is to help cells burn fat. When Choi and colleagues gave metformin to the specially bred mice, the drug restored the animals' ability to make memory T cells.

This led the researchers to wonder what would happen if they gave metformin to normal mice. So they injected the mice with doses of an experimental cancer vaccine that, under normal circumstances, does not protect the animals. But in mice given metformin, the vaccine was vastly more effective at preventing cancer.

"The finding was very unexpected. We were lucky," Choi tells WebMD.

The serendipity may pay off in big ways.

"The findings do not mean that if you take metformin you automatically have better memory responses," Choi says. "But this widely used drug might enhance vaccination programs. If we combine our finding with those strategies, we may be able to improve vaccine efficacy."

Source : www.webmd.com

read more» Read more...

New Diabetes Drug Cycloset Approved

The FDA has approved a new drug, called Cycloset, to improve blood sugar control in adults with type 2 diabetes, in addition to diet and exercise.

Cycloset takes a new approach to treating type 2 diabetes. It boosts levels of a chemical called dopamine, which helps nerve cells communicate.

Cycloset is taken orally in the morning, within two hours of waking, and with food.

It's not clear how Cycloset improves glycemic control in humans. But studies in diabetic animals show that boosting dopamine activity at a particular time of day can "reset" the biological clock to improve metabolism problems related to diabetes, according to VeroScience, the company that developed Cycloset.

In a yearlong trial of 3,070 adults with type 2 diabetes, Cycloset trumped a placebo at improving HbA1c levels, which gauge blood sugar control, over the previous two to three months. In that trial, 39% of patients taking Cycloset met the HbA1c goal, compared to 11% of patients taking the placebo.

In addition, patients taking Cycloset were less likely to have a heart attack or stroke, or to die of heart disease.

During the clinical trial, 24% of the patients in the Cycloset group dropped out of the study, compared to 15% of the patients taking placebo. Gastrointestinal side effects, particularly nausea, were the main reason patients taking Cycloset quit the study.

The most commonly reported adverse events were nausea, fatigue, vomiting, headache, and dizziness. None of those cases was serious, and side effects were more likely to happen when patients first started taking Cycloset.

Cycloset's active ingredient, bromocriptine mesylate, isn't a new drug. It's been used in other formulations to treat conditions including Parkinson's disease, usually at higher doses, according to Cycloset's prescribing information.

Source : www.medicinenet.com

read more» Read more...

New Diabetes Drug Cycloset Approved

The FDA has approved a new drug, called Cycloset, to improve blood sugar control in adults with type 2 diabetes, in addition to diet and exercise.

Cycloset takes a new approach to treating type 2 diabetes. It boosts levels of a chemical called dopamine, which helps nerve cells communicate.

Cycloset is taken orally in the morning, within two hours of waking, and with food.

It's not clear how Cycloset improves glycemic control in humans. But studies in diabetic animals show that boosting dopamine activity at a particular time of day can "reset" the biological clock to improve metabolism problems related to diabetes, according to VeroScience, the company that developed Cycloset.

In a yearlong trial of 3,070 adults with type 2 diabetes, Cycloset trumped a placebo at improving HbA1c levels, which gauge blood sugar control, over the previous two to three months. In that trial, 39% of patients taking Cycloset met the HbA1c goal, compared to 11% of patients taking the placebo.

In addition, patients taking Cycloset were less likely to have a heart attack or stroke, or to die of heart disease.

During the clinical trial, 24% of the patients in the Cycloset group dropped out of the study, compared to 15% of the patients taking placebo. Gastrointestinal side effects, particularly nausea, were the main reason patients taking Cycloset quit the study.

The most commonly reported adverse events were nausea, fatigue, vomiting, headache, and dizziness. None of those cases was serious, and side effects were more likely to happen when patients first started taking Cycloset.

Cycloset's active ingredient, bromocriptine mesylate, isn't a new drug. It's been used in other formulations to treat conditions including Parkinson's disease, usually at higher doses, according to Cycloset's prescribing information.

Source : diabetes.webmd.com

read more» Read more...

FDA Faces Tough Choice On New Diabetes Drug

Does a promising new class of diabetes drugs boost the risk of a rare thyroid tumor that may take decades to develop?

That's the confusing and almost unanswerable question Food and Drug Administration regulators find themselves facing after a federal advisory panel on Thursday split its vote on whether to approve Novo Nordisk's promising new diabetes drug liraglutide.

The drug is one of a new class of injected compounds called GLP-1 drugs that lower blood sugar levels while also causing weight loss.

Liraglutide would compete with Eli Lilly's ( LLY - news - people ) and Amylin Pharmaceuticals ( AMLN - news - people ) rival drug Byetta. Doctors like the drugs because they provide a potent new option for treating patients whose disease cannot be controlled with existing diabetes pills. If approved, Liraglutide might steal market share from Byetta, as it can be injected just once a day, compared with twice a day for Byetta.

But the panel was worried about animal studies showing that liraglutide causes a rare type of thyroid cancer called medullary thryroid cancer in both mice and rats. Novo Nordisk told Forbes that there is no evidence that it causes such cancers in humans. But the panel of doctors said that Novo had not ruled out the possibility. It deadlocked six to six on whether liraglutide should be approved. The 13th doctor on the panel was so confused by the issue he abstained on the key vote.

At the hearing, the FDA said it was "very rare" for a drug that causes cancer in multiple animal species to be approved.

The thyroid concern threatens to spill over and hit Amylin Pharmaceuticals and Eli Lilly, which are also testing a long-acting formulation of Byetta. Some members of the panel were worried that any thyroid risk might apply to the whole class of drugs. "It certainly sounded from what I heard today that this may be a class effect for any of the longer-acting agents," said Peter Savage of the National Institutes of Health, who voted against approval.

Novo Nordisk shares declined 8.3% at midday Friday, while shares of Amylin Pharmaceuticals also dipped 8.7%. In a report downgrading Amylin, Lazard Capital Markets analyst Matthew Osborne called the rodent thyroid cancer problem "completely unanticipated" and said that the thyroid findings "raise concerns" that the long-acting version of Byetta could be delayed as well, or face restrictions that limit its sales potential.

"There is currently no clinical evidence that thyroid cancer is a GLP-1 class effect. There is no identified association between thyroid C-cell carcinoma and [Byetta] based upon clinical trial and post-marketing data," Amylin Pharmaceuticals said in a e-mailed statement in response to a Forbes query.

A cloud over the injected GLP-1 drugs would be good news for Merck ( MRK - news - people ), which sells a rival pill drug Januvia. It also could help for Bristol-Myers Squibb ( BMY - news - people ) and AstraZeneca ( AZN - news - people ), whose experimental diabetes pill saxagliptin sailed through the same advisory panel on April 1 with no problems.

Novo contends the mice and rat data are irrelevant to humans. It hopes to get the drug approved by promising to carefully study the thyroid issue in a big 9,000-person safety trial that will also look at cardiovascular safety. "In my mind there is not a human health hazard based on what has been shown to date," says Novo Nordisk Chief Scientific Officer Mads Krogsgaard Thomsen. Liraglutide does not boost thyroid cancer risk in monkeys even when they are given enormous doses, he says.

But he admits that the intense discussion about the rodent thyroid cancers took Novo Nordisk by surprise--as it did Wall Street. "We knew we were going to discuss the issue, but we did not know [it was going to be] the overarching dominating thing," says Thomsen.

Going into the meeting, the main focus was expected to be cardiovascular safety. This has been a big subject of scrutiny for all diabetes drugs ever since Avandia from GlaxoSmithkline was linked to heart problems in 2007. But cardiovascular concerns turned out to be a comparatively minor point of discussion on Thursday.

Instead, the debate centered on the unsettling mouse and rat studies. Committee members were not convinced by Novo's contention that the rodent findings would not apply to humans. "I felt the animal data were worrisome and didn't see sufficient human data to feel reassured," panel member Peter Savage said at the hearing. "I am not sure the benefits of adding this drug at this time outweigh the trade-offs."

The problem is that medullary cancer is so rare and develops so slowly over decades, that there is be no easy way to rule out the possibility that the drugs might boost cancer risk decades after people start taking them. "We are not talking about something that is going to suddenly pop up and kill someone in six months or a year," explained panel member Michael Tuttle of Memorial Sloan-Kettering Cancer Center. "The risk is, are they going to develop [thyroid tumors] years down the road." He voted for approval because he thought there was no obvious study that could be done to rule out the risk.

Nothing is likely to answer the question definitely short of approving the drug, letting millions use it, and waiting to see whether more people get medullary thyroid cancer. "We are facing a modified Hobson's choice," said committee chair Kenneth Burman of Washington Hospital Center. "Should we expose the entire population to the potential risk even though it is probably low?" He voted against approval but said more human data showing no thyroid risk could easily change his mind.

Novo Nordisk may already have some of the data Burman wants. Thomsen says new data from recently completed two-year human studies of liraglutide show no hints of thyroid problems in roughly 1,500 patients. These data are so new they weren't part of the company's original submission to the FDA.

Cardiologist Marvin Konstam of Tufts Medical Center, the potential deciding vote on the panel, abstained. "I can think of no better question for a cardiologist to abstain with," he said. "I don't come away with a clear opinion what to do."

The panels' non-decision puts the question squarely back in front of the full FDA. Should it approve the drug right away but with restrictions and demands for further studies? Should it demand additional, longer-term human studies of liraglutide before approving the drug that could reassure people that the risk is low? Should the drug be rejected entirely? And if the FDA thinks thyroid cancer is a real risk, does it also apply to other drugs like Byetta?

At the end of the hearing, the FDA itself seemed somewhat confused as to what to do next. "I am somewhat comforted that you have struggled" with the thyroid concern, FDA division director Mary Parks told the panel. Now, she said, "we will take on the difficult task of next steps."

The GLP-1 drugs are the result of decades-old breakthroughs in understanding blood-sugar regulation. In the late 1970s, Harvard Medical School researcher Joel Habener serendipitously discovered a hormone in monkfish called GLP-1 (glucagon-like peptide). It stimulated the body to secrete just the amount of insulin needed to control blood sugar, but not too much.

But GLP-1 turned out to be an impractical medicine, as it degrades quickly once injected into the body. But in the early 1990s endocrinologist John Eng at the VA Medical Center in the Bronx found a chemical in venomous Gila monster saliva that mimicked the effects of GLP-1. When he injected it into diabetic mice, it controlled their blood sugar all night long. The Gila monster finding led to Byetta, a synthetic version of what is found in the lizards.

Novo's Liraglutide is a modified version of the human GLP-1 that lasts longer in the bloodstream.

Source : www.forbes.com

read more» Read more...

Biodel to Submit New Drug Application for VIAject(R) to FDA

Biodel Inc. announced today its plan to submit a new drug application to the U.S. Food and Drug Administration in the second half of this year for approval to market VIAject for the treatment of diabetes. VIAject is Biodel's investigational ultra-rapid-acting injectable human insulin intended for meal-time use by people with Type 1 and Type 2 diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed Phase 3 studies of VIAject in patients with Type 1 and Type 2 diabetes.

Preliminary results from the Phase 3 studies were reported last year at the 44th Annual Meeting of the European Association for the Study of Diabetes . Biodel intends to seek approval for the 100 IU/cc liquid formulation of VIAject, which is bioequivalent to the two-part 25 IU/cc lyophilized powder formulation of VIAject that was used in the company's pivotal Phase 3 clinical trials. Biodel believes that results from both Phase 3 studies showed that VIAject was non-inferior to Humulin R, the leading recombinant human insulin, in terms of blood glucose control, when measured by the mean change in patients' hemoglobin A1c levels (HbA1c). The results also demonstrated lower incidence of hypoglycemia and less weight gain in patients receiving VIAject as compared to patients receiving Humulin R.

At the EASD conference, Biodel reported that preliminary efficacy results from patients with Type 1 diabetes in India were not comparable to results from patients in the United States and Germany. While non-inferiority of VIAject(R: 28.78, -1.0292, -3.45%) to Humulin R was achieved without the data from India, it was not achieved when the data from India was included. Biodel identified probable causes for the variance in the data from India with the assistance of regulatory consultants and presented the results to the FDA in its pre-NDA briefing package. Among the causes noted in the briefing package, an identifiable subset of blood samples from patients in India was found to be compromised due to excessive heat exposure in transit to a central laboratory. When the compromised samples are removed from the efficacy analysis, non-inferiority in both the Type 1 and Type 2 trials is achieved.

After reviewing all of the data from the two pivotal Phase 3 clinical trials with regulatory consultants and meeting with FDA staff, the company has decided to proceed with the submission of its NDA under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. The FDA will review any submission the company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.

Biodel's chairman and chief executive officer, Dr. Sol Steiner, stated: "After investigating the cause of the anomalous data in India and discussing our findings with the FDA, we are now comfortable proceeding with the preparation and submission of the NDA for VIAject in the second half of this year. This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal Phase 3 clinical trials, which we believe met the endpoint of non-inferior change in HbA1c over six months. In the meantime, we continue to collect safety data from the open-label extensions of the Phase 3 trials and are proceeding with plans to conduct additional development work this year to further differentiate VIAject from the rapid-acting insulin analogs."

Source : www.foxbusiness.com

read more» Read more...