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FDA News

August 17, 2006

Media Inquiries:
Laura Alvey, 301-827-6242
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FDA Approves New Medical Use for Plavix
Drug Benefits Patients with Common Form of Heart Attack

The Food and Drug Administration (FDA) today approved the use of Plavix (clopidogrel bisulfate) for patients who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI), who are not going to have coronary artery repair (angioplasty).

A STEMI is a severe heart attack caused by the sudden, total blockage of an artery. In STEMI patients, Plavix prevents subsequent blockage in the already-damaged heart vessel, which could lead to more heart attacks, stroke - and possibly death.

FDA approved Plavix in November 1997 to decrease platelet function in people who suffer from acute coronary syndrome (ACS). Platelets are the sticky blood cells that help to form a clot and can contribute to blocked coronary arteries

According to the American Heart Association, each year an estimated 500,000 Americans have a STEMI heart attack.

"Plavix has demonstrated that it can help reduce these post-STEMI events for patients who suffer certain kinds of heart attacks," said Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research.

Two studies support the effectiveness of Plavix in treating STEMI heart attack patients. A large trial, the Clopidogrel and Metoprolol in Myocardial Infarction Trial (COMMIT) study, demonstrated that Plavix, when combined with other standard treatments including thrombolysis, a procedure to dissolve clots, reduced mortality and also reduced the combined number of recurrent heart attacks, strokes and deaths. COMMIT was a randomized, double-blind, placebo-controlled trial of 46,000 patients conducted in China.

The findings in COMMIT in China are supported by the results of the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) study. CLARITY was a clinical trial of 3,500 patients undergoing thrombolysis for STEMI heart attacks. CLARITY showed that the coronary artery blood flow was better with clopidogrel treatment compared to placebo.

Serious side effects of Plavix include bleeding and, rarely, low white blood cell counts or thrombotic thrombocytopenic purpura (low platelet counts with spontaneous bleeding and clotting). \Plavix is manufactured by Sanofi Aventis of Bridgewater, NJ.

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