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Sanofi-aventis', Bristol-Myers Squibb's Plavix Receives Expanded FDA Approval
by Marie-Eve Laforte -- August 17, 2006

The FDA approved Thursday Sanofi-aventis' and Bristol-Myers Squibb's Plavix (clopidogrel) for patients who have suffered an acute ST-segment elevation myocardial infarction (STEMI) and who will not undergo angioplasty.

In a statement released by the FDA, the agency said the additional indication was granted based partially on results from the randomized, placebo-controlled COMMIT trial involving 46 000 STEMI heart attack patients. Data demonstrated that patients who took Plavix with other standard treatments experienced a reduction in mortality, and a reduction in the combined number of recurrent heart attacks and strokes, and death.

In the US , Plavix is indicated to decrease platelet function in people who suffer from acute coronary syndrome. The drug garnered global sales of approximately $6 billion last year.

Reference Articles

Bristol-Myers, Sanofi Win U.S. approval of added use for Plavix - (Bloomberg)

FDA approves expanded use for Plavix - (BusinessWeek)

Agency approves Plavix for heart attack care - (CNN Money)

FDA approves new medical use for Plavix - (FDA)

FDA approves new use for Plavix - (Morningstar)

FDA approves new indication for Plavix offering new option for patients with most severe type of heart attack - (SmartMoney)