Approval of New drug for Heart patients

Here is the good news for all the heart patients of the world! The new anti-clotting drug of Eli Lilly & Co. and Daiichi Sankyo Co., named as Effient have been approved for sales by U.S authorities. This drug may take up one-fifth of the market from the second best selling drug- Plavix, which is largely sold out by Bristol-Myers Squibb Co. and Sanofi- Aventis SA.

Lilly’s medicine, prasugrel, which will be sold under the name of Effient got its clearance from Food and Drug Administration yesterday itself. This drug carries strict warning of increased risk of fatal bleeding in its label known as black box. Effient is available in markets in 5 and 10 milligram tablets for nullifying the chances of occurrence of heart attacks and strokes in a patient who are undergoing angioplasty treatment. But Tony Butler, who is an analyst at Barclay capital in New York expresses that the strict warning of this drug may affect its sales by $1.5 billion globally.

Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston claimed in one of his meeting with clients on April 7 that Effient yearly sales will reach up to $1.9 billion by 2015. For New York based Bristol Myers and Paris based Sanofi, Plavix was an $ 8.2 billion seller last year.

Effient was out for sale in Europe in month of April and it captured nearly 20 percent of Plavix market. Tim Anderson, an analyst in Sanford C. Bernstein & Co. declared it to be the most preferred and prescribed drug for patients who suffers from acute coronary syndrome and are likely to undergo angioplasty procedure.

Initially the approval procedures for Effient face lot of hardships as one of the drug critic-Sanjay Kaul was removed from the panel of FDA advisors. FDA thought that the articles written by this critic related to the safety and effectiveness of the drug were biased. In a telephonic interview yesterday, the founder of Krensavage Asset Management LLC in New York said that FDA should go for another trail because the drug can cause tremendous bleeding in patients.

Effient has been designed to keep the blood platelets sticking from each other and form clot that can directly lead to strokes, heart attacks and finally death of a person. This drug was fully tested on patients suffering from heart attacks and who are undergoing angioplasty.

To persuade the doctors to make more use of Effient drug, it’s superiority over cheaper Plavix drug was made through various clinical trials. Consequently Plavix loses its patent rights with best seller of drugs company- Bristol-Myers in 2011.

Daiichi and Lilly carried out research involving 13608 patients in 30 countries for more than a year to check the effectiveness of their drug. The good news was that Effient was successful in preventing 23 more heart attacks than Plavix for every 1000 patients, but unfortunately it causes 6 more cases of excessive bleeding.

The American college of cardiologists in March 2008 founded that Effient was effectual in stopping blood clots in stent patients than the cheaper drug Plavix.

Recently Daiichi Sankyo and Lilly have started a new study known as trilogy to find out whether their drug is more suitable in treating patients from acute coronary syndrome along with other heart ailments than regular Plavix drug.

Very soon Daiichi Sankyo will be marketing the Effient drug in Japan and other countries as well. Lilly will booked the sales while Daiichi Sankyo will receive revenues from these sales.

Source : ub-news.com

read more» Read more...

Lilly drug helps lung cancer patients live longer

The use of Eli Lilly and Co's Alimta following successful chemotherapy treatment helped patients with advanced lung cancer live significantly longer, according to data released on Saturday.

The study, presented at the American Society of Clinical Oncology (ASCO) meeting in Orlando, Florida, also confirmed that the benefit from Alimta is primarily limited to the more common nonsquamous type of non-small cell lung cancer.

Patients in the study with that type of cancer who were treated with Alimta as a so-called maintenance therapy lived more than five months longer than those who got a placebo.

"This should become the standard of care," Dr. Chandra Belani, deputy director of the Penn State Cancer Institute and the study's lead investigator, said in an interview.

"This is the first time that there is a benefit of five months in nonsquamous patients. As the cumulative toxicity is minimal it can be given for a prolonged duration of time," Belani said.

Alimta, known chemically as pemetrexed, is approved for use in combination with chemotherapy as an initial treatment for advanced nonsquamous non-small cell lung cancer. Approval as a maintenance therapy -- to delay worsening of the disease after chemotherapy has stalled tumor growth -- would add a lucrative new revenue source for the medicine.

Alimta had sales of $1.15 billion in 2008.

"This is the next step in the overall management (of the disease)," Belani said.

"If you can give it for a prolonged duration of time you then can change the acute nature of the disease to a chronic disease. That's the intent, that you can maintain that state of response with the initial chemotherapy," Belani explained.

Preliminary results from the 663-patient, late-stage study presented at last year's ASCO meeting demonstrated Alimta's ability to delay disease progression when used as a maintenance therapy. The latest data for the first time showed a significant improvement in overall survival, researchers said.

Overall survival -- the extension of a patient's life -- is considered the gold standard by physicians and by health regulators making approval decisions.

All patients in the study had advanced or metastatic non-small cell lung cancer that had not progressed after four cycles of platinum-based chemotherapy.

In the overall patient population, those who received Alimta lived for an average of 13.4 months versus 10.6 months for patients in the placebo group. Among patients with the nonsquamous type of cancer, those who got Alimta lived an average of 15.5 months compared with 10.3 months in the placebo group. Both results were considered to be statistically significant, Belani said.

The lack of benefit among patients with the squamous subtype confirmed what had been seen in prior Alimta studies.

Side effects more common in the Alimta group were fatigue and low white blood cell counts, researchers said. There were no drug-related deaths in the study.

read more» Read more...