Sanofi-Aventis, Bristol-Myers get expanded European Plavix indication, withdraw dronedarone

By Lisa Kerner

Charlotte, N.C., Sept. 7 - Sanofi-Aventis and Bristol-Myers Squibb Co. announced that the European Commission granted a new indication for the antiplatelet agent Plavix (clopidogrel bisulfate) to include patients with ST-segment Elevation acute Myocardial Infarction (STEMI) who are eligible for thrombolytic therapy.

STEMI is a severe heart attack in which an artery supplying blood to the heart is completely locked.

The approval was based on the results of two clinical trials in which STEMI patients were treated with Plavix taken with acetyl salicylic acid (ASA) and standard therapy.

"Plavix taken with ASA 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," said Keith A.A. Fox, professor of cardiology at the University of Edinburgh, in a news release.

Sanofi-Aventis also announced it is withdrawing its European application for Marketing Authorization of dronedarone (Multaq), 400 mg film-coated tablets for use in the treatment of atrial fibrillation/atrial flutter.

The company is unable to adequately assess the benefit-risk balance of the product in the timeframe provided but said it plans to resubmit a European application in 2008.

Sanofi-Aventis is a Paris-based pharmaceutical company.

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

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