FDA clears Plavix for new use

2006-09-11

US regulators gave the nod on Friday to Sanofi-Aventis and Bristol-Myers Squibb’s blood thinner Plavix for use in the treatment of patients with severe heart attack. Specifically, the US Food and Drug Administration gave Plavix (clopidogrel) the all clear to treat the more than 300,000 Americans a year that suffer an ST elevation acute myocardial infarction (STEMI) - in which an artery supplying the heart with blood is generally totally blocked. The approval follows a green light from European regulators earlier in the week. "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," said Marc Sabatine, TIMI Study Group, Brigham and Women's Hospital. "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.” Results from these clinical trials clearly demonstrated Plavix’ benefit in this setting. In the COMMIT study, Plavix in combination with aspirin and standard therapy was shown to cut the relative risk of death in STEMI patients by 7% and the relative risk of the combination of myocardial infarction, stroke or death by 9%. In the CLARITY - TIMI 28 trial, the combination was shown to significantly reduce the odds of STEMI patients having a second heart attack or death by 36%. Plavix is currently the world second biggest selling drug, with US sales alone hitting $2.7 billion, but both Sanofi-Aventis and B-MS were recently forced to cut its sales projections for the year, following a court decision which blocked Canadian group Apotex from selling generic clopidogrel but stopped short of ordering a recall of that which has already infiltrated the market. Additional use of Plavix for severe heart attack could help the group’s recoup some of the lost sales as a result of the generic challenge. A new trial to settle the ongoing Plavix patent saga has been set for January 22, 2007.

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