Sanofi, Bristol-Myers seek FDA approval of new indication for Plavix

By E. Janene Geiss

Philadelphia, Jan. 18 - sanofi-aventis and Bristol-Myers Squibb Co. announced Wednesday that the Food and Drug Administration has accepted for review a Supplemental New Drug Application for the antiplatelet agent Plavix (clopidogrel bisulfate) for treatment of patients with acute ST-segment elevation myocardial infarction (Stemi).

The FDA has designated the filing for priority review, which is granted to applications in which a new indication or new drug product, if approved, would present a significant improvement compared to currently available therapies or marketed products, according to a company news release.

The companies also have submitted a filing to the European Medicines Evaluation Agency for a Stemi indication in the European Union, officials said.

Stemi is a heart attack in which an artery is generally blocked completely for sufficient time to cause heart muscle damage. This blockage is caused by clot formation in the arteries, which is also known as atherothrombosis. There are about 10 million heart attacks per year worldwide. In the United States alone, the estimated 500,000 Stemi events per year represent one-third of all heart attacks suffered in the country, the news release said.

Plavix is approved for early and long-term risk reduction in patients at risk for atherothrombotic events.

The FDA filing is based on the findings of two recent clinical trials that treated Stemi patients with Plavix administered on a background of standard therapy, officials said.

In one of those two trials, patients were followed for 28 days. In the other trial, patients were followed for 30 days.

Both studies were presented at the annual scientific session of the American College of Cardiology in March 2005 and subsequently published in the Lancet and the New England Journal of Medicine.

Plavix is marketed worldwide by sanofi-aventis and Bristol-Myers Squibb as Plavix and Iscover.

Based in Paris, sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe.

Bristol-Myers Squibb is a Princeton, N.J., pharmaceutical and related health care products company.

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