Plavix Gets New Indication

Sanofi-Aventis and Bristol-Myers Squibb received approval from the FDA for the sNDA for antiplatelet agent Plavix in the reduction in patients with acute ST-segment elevation myocardial infarction (STEMI) in the rate of death from any cause and the rate of a combined endpoint of re-infarction, stroke or death. STEMI is a severe acute heart attack in which a coronary artery is generally blocked completely. These blockages are caused by clot formation in the arteries, a life-threatening complication of an underlying disease known as atherothrombosis.

The FDA approval was based on the results of two trials of more than 48,000 patients in which STEMI patients treated with Plavix taken with aspirin and standard therapy were compared to STEMI patients treated with placebo taken with aspirin and standard therapy. Results demonstrated that in the 28 days following randomization, clopidogrel, taken with aspirin and standard therapy, reduced the relative risk of death in STEMI patients by 7%, and reduced the relative risk of the combination of MI, stroke or death by 9%. In the second trial, clopidogrel taken with aspirin and other standard therapy including thrombolytics significantly reduced the odds of STEMI patients having another occluded artery, or a second heart attack or death by 36% by day eight of hospitalization or discharge.