FDA Grants Plavix Priority Review

Sanofi-Aventis and Bristol-Myers Squibb’s sNDA for Plavix for treatment of patients with acute ST-segment elevation myocardial infarction (STEMI) has been accepted for review by the FDA. 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.

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. The companies have also submitted a filing to the EMEA for a STEMI indication in the EU. The FDA filing is based on the positive findings of two recent clinical trials that treated STEMI patients with Plavix administered on a background of standard therapy.