FDA grants priority review to new drug for acute STEMI

Sanofi-aventis and Bristol-Myers Squibb Co. announced recently that the US Food and Drug Administration (FDA) has accepted for review a supplemental new drug application for the antiplatelet agent clopidogrel bisulfate for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).

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 10 million heart attacks per year worldwide. In the US alone, the estimated 500,000 STEMI events per year represent one-third of all heart attacks suffered in the country.

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.

Clopidogrel 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 clopidogrel administered on a background of standard therapy.

In the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) trial, patients were followed for 30 days.

In the CLARITY-TIMI 28 (CLopidogrel as Adjunctive ReperfusIon TherapY — Thrombolysis In Myocardial Infarction Study 28) trial, patients were followed for 28 days.

Both studies were presented at the 54th Annual Scientific Session of the American College of Cardiology in 2005 and subsequently published in the Lancet and the New England Journal of Medicine, respectively.

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 hospitalization in the United States.