FDA GRANTS PRIORITY REVIEW TO SANOFI-AVENTIS' LOVENOX SNDA

Sanofi-aventis announced that the FDA has granted priority review to its supplemental new drug application (sNDA) for the anticoagulant Lovenox to treat acute ST-segment elevation myocardial infraction (STEMI), or acute heart attack. STEMI occurs when an artery is completely blocked long enough to cause damage to the heart, according to the company.

FDA grants priority review to applications for a new drug or indication that, if approved, would present a significant improvement over currently available therapies, according to sanofi-aventis.

The company's application is based on the results of the ExTRACT-TIMI 25 trial, which was published in the New England Journal of Medicine. The study enrolled more than 20,000 acute STEMI patients who were eligible to receive fibrinolytic therapy.

Lovenox is a low-molecular-weight heparin approved in 96 countries for a total of seven indications involved with the prophylaxis and treatment of thromboembolic disease.