NDA Submitted for Azilsartan Medoxomil

Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil , an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension. Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

"The NDA submission for azilsartan medoxomil is built upon a robust data package and is a significant milestone for Takeda," said Nancy Joseph-Ridge, M.D., general manager of Takeda's Pharmaceutical Development Division. "We are proud to build upon our global expertise in the cardiovascular therapeutic area with this filing, and believe this compound, once approved, will provide an important treatment option for hypertensive patients and the health care providers who manage them."

The NDA submission was supported by seven phase 3 clinical trials involving more than 5,900 patients. The safety and efficacy of azilsartan medoxomil was studied for initial therapy as a once-daily oral monotherapy or in combination with other antihypertensive medications, including chlorthalidone and amlodipine, and was also studied in comparison to olmesartan medoxomil, valsartan and ramipril. Results from five of the pivotal phase 3 studies will be presented May 1-4, 2010, at the American Society of Hypertension Inc. (ASH), 25th Annual Scientific Meeting and Exposition in New York.

About Azilsartan Medoxomil

Discovered by Takeda, azilsartan medoxomil, also known as TAK-491, is an angiotensin II receptor blocker currently in development for the treatment of hypertension, or high blood pressure, either used alone or in combination with other classes of antihypertensive agents. Angiotensin II, a vasopressor, is a hormone that naturally exists within the body and plays a key role in cardiovascular function. The hormone induces contraction, or tightening, of blood vessels and thus plays an important role in mediating hypertension. The most commonly reported treatment-related adverse reactions (>/=1%) in phase 3 clinical trials were dizziness (2.1%), increased blood creatine phosphokinase (1.1%) and diarrhea (1.0%).

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United Therapeutics wins FDA OK for new hypertension drug

Shares of United Therapeutics Corp. rose nearly 12 percent Tuesday after the company revealed that it has won U.S. Food and Drug Administration approval to sell the drug Adcirca for the treatment of pulmonary arterial hypertension.

Clinical development of Adcirca was led by Eli Lilly & Co.

Adcirca is a prescription medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature. Adcirca contains the same active ingredient as Cialis (tadalafil), which is marketed by Eli Lilly & Company to treat erectile dysfunction in more than 100 countries.

The American Lung Association says Pulmonary arterial hypertension can cause shortness of breath, chest pain and eventually heart failure. There is no cure. The disease is more common in women and often linked to other conditions such as heart or lung disease, infection with HIV, and autoimmune disorders.

Shares of Silver Spring-based United Therapeutics Corp closed at $74.43, up 11.86 percent.

Last November, United Therapeutics suffered a scientific blow with news of a three-month delay in a Food and Drug Administration decision on its inhaled Remodulin treatment. An experimental oral version of the drug failed late-stage clinical trials.

That's when the company signed a licensing agreement with Eli Lilly & Co. to develop and market its Cialis drug for the treatment of pulmonary arterial hypertension in the United States -- a deal that company officials said would double its revenues if the drug were to be approved for that disease by federal regulators.

United Therapeutics has a research and development outpost in Research Triangle Park.

Source : www.bizjournals.com

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A New Drug to Fight Portal Hypertension?

Although portal hypertension, the most significant complication for patients with liver cirrhosis, can become life-threatening, doctors do not have many effective treatment options available to them.

A new study in the April issue of Hepatology, however, suggests the drug sorafenib — already approved in several countries for treatment of kidney and liver cancer — dramatically improves the health of rats with the condition.

In the experiment, rats took sorafenib orally every day for two weeks and displayed no adverse effects from the treatment. The drug is designed to inhibit the growth of new blood vessels, and researchers observed an 80 percent decrease in the areas around the liver where fibrosis and inflammation also improved.

While the researchers stress that a "very careful approach" is needed in potential human trials of the drug, they encourage their colleagues to more closely examine the role of similar therapeutic agents that block blood vessel growth — called antiangiogenesis therapy - in patients with cirrhosis and portal hypertension.

"Taking into account the limitations of translating animal study results into humans, we believe that our findings will be stimulating for consideration of sorafenib as an effective therapeutic agent in patients suffering from advanced portal hypertension," write the study authors, led by Marc Mejias and Mercedes Fernandez from the August Pi i Sunyer Institute of
Biomedical Research in Barcelona.

An editorial in the same issue of Hepatology by Vijay Shah of the Mayo Clinic and Jordi Bruix of Barcelona, titled "Antiangiogenic therapy: Not just for cancer anymore?" hails the findings. "It is obvious that a new avenue for pharmacologic intervention in patients with cirrhosis has emerged," they conclude.

Source : www.miller-mccune.com

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