Sanofi-Aventis, Bristol-Myers' Plavix gets FDA approval for new indication

By Elaine Rigoli

Tampa, Fla., Aug. 17 - Sanofi-Aventis and Bristol-Myers Squibb Co. said the Food and Drug Administration has approved the supplemental New Drug Application for the antiplatelet agent Plavix (clopidogrel bisulfate) to reduce the rate of death from any cause and the rate of a combined endpoint of re-infarction, stroke or death in patients with acute ST-segment elevation myocardial infarction.

"Clopidogrel taken with aspirin has previously been shown to reduce the risk of death, recurrent heart attacks or stroke in patients with unstable angina or less severe heart attacks. Now, based on the positive results of two clinical trials, Commit and Clarity - TIMI 28, clopidogrel has been approved by the FDA for use with aspirin in patients with the most severe types of heart attacks, thereby extending the benefit of clopidogrel to patients across the spectrum of acute coronary syndromes," TIMI study group author Marc Sabatine said in a news release.

The FDA approval was based on the results of two clinical trials of more than 48,000 patients in which ST-segment elevation myocardial infarction patients treated with Plavix taken with aspirin and standard therapy were compared to ST-segment elevation myocardial infarction patients treated with a placebo taken with aspirin and standard therapy.

Sanofi-Aventis is a pharmaceutical company based in Paris.

Bristol-Myers Squibb is a global pharmaceutical company based in Princeton, N.J.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.