Sanofi-aventis granted FDA priority review for Plavix application

By Lisa Kerner

Erie, Pa., Jan. 18 - Sanofi-aventis and Bristol-Myers Squibb Co. announced that the U.S. Food and Drug Administration has accepted for priority 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).

Stemi is a heart attack due to clot formation in the arteries (atherothrombosis), with resulting damage to the heart muscle, according to a company release. There are an estimated 500,000 Stemi events each year in the United States.

Plavix is a prescription antiplatelet medicine taken once a day that helps keep platelets in the blood from sticking together and forming clots. Since its initial FDA approval on November 17, 1997, Plavix has been used to treat millions of patients worldwide, said the company.

FDA priority review status 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 the release.

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. In the Commit/CCS-2 trial, patients were followed for 28 days. In the Clarity-TIMI 28 trial, patients were followed for 30 days.

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

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

Paris-based Sanofi-aventis is developing products in major therapeutic areas including cardiovascular, thrombosis, oncology, metabolic diseases, and vaccines.

Bristol-Myers Squibb, based in New York, is a global pharmaceutical and related health care

products company.

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