sanofi-aventis announced the Food and Drug Administration (FDA) has accepted for review a supplemental new drug application (sNDA) for the anticoagulant Lovenox (enoxaparin sodium injection) for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI), a type of acute heart attack.

Stemi is a heart attack in which an artery is generally completely blocked for sufficient time to cause heart muscle damage. This blockage is caused by blood clot formation in the heart arteries.

The FDA has designated the filing for priority review, which is granted to applications in which a new indication or a new drug, if approved, would present a significant improvement compared to currently available therapies or marketed products. The company has also submitted a filling in European countries including France, Germany, UK, Italy and Spain.

Lovenox is a low-molecular weight heparin (LMWH) approved in 96 countries with seven indications (which may vary from one country to another) for the prophylaxis and treatment of thromboembolic disease, including prophylaxis of ischemic complications of unstable angina and non-Q-wave (non-ST-segment elevation) myocardial infarction and the prophylaxis of Venous Thromboembolism (VTE), a condition that includes Pulmonary embolism (PE) and deep-vein thrombosis (DVT).

The FDA filing is based on the results of the landmark ExTRACT-TIMI 25 trial (Enoxaparin and Thrombosis Reperfusion for Acute Myocardial InfarCtion Treatment, Thrombolysis In Myocardial Infarction - Study 25), which was published in the April 2006 edition of the New England Journal of Medicine and presented at the 2006 American College of Cardiology's 55th Annual Scientific Session. The study included more than 20,000 acute STEMI patients who were eligible to receive fibrinolytic therapy.

Enoxaparin is an anticoagulant of the low molecular weight heparin (LMWH) class. Its clinical applications are linked to its antithrombotic properties. It is used to inhibit clot formation in venous or arterial vessels to avoid potential acute or chronic complications of venous or arterial thrombosis such as pulmonary embolism, myocardial infarction or death of cardiovascular origin. As with all anticoagulants, the most frequently reported side effect for enoxaparin is bleeding. Lovenox® is the most widely studied LMWH, with 15 years of use in the treatment of 130 million patients in 96 countries.