Sanofi-Aventis and Bristol-Myers Squibb Company have received a review from the US FDA for a supplemental new drug application (sNDA) for the antiplatelet agent Plavix (clopidogrel bisulfate) for treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).

The FDA has designated the filing for priority review, which is granted to applications in which a new indication or new drug product, if approved, would present a significant improvement compared to currently available therapies or marketed products. The companies have also submitted a filing to the European Medicines Evaluation Agency (EMEA) for a STEMI indication in the European Union.

Plavix is approved for early and long term risk reduction in patients at risk for atherothrombotic events. In the CURE trial, patients with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) were followed for up to one year, and in the CAPRIE trial, patients with recent MI, recent ischemic stroke, or established peripheral artery disease were followed for up to three years.

The FDA filing is based on the findings of two recent clinical trials that treated STEMI patients with Plavix administered on a background of standard therapy. Acute ST-segment elevation myocardial infarction (STEMI), along with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) are the three conditions classified as acute coronary syndrome (ACS). ACS is a major cause of emergency medical care and hospitalisation in the United States.

STEMI is a heart attack in which an artery is generally blocked completely for sufficient time to cause heart muscle damage. This blockage is caused by clot formation in the arteries, which is also known as atherothrombosis. There are approximately ten million heart attacks per year worldwide; in the United States alone, the estimated 5, 00,000 STEMI events per year represent one-third of all heart attacks suffered in the country.