Sanofi-aventis announced today that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the anticoagulant Lovenox(R) (enoxaparin sodium injection) for the treatment of patients with acute ST- segment elevation myocardial infarction (STEMI). Lovenox(R) has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute STEMI receiving thrombolysis and being managed medically or with Percutaneous Coronary Intervention (PCI).

STEMI is a severe type of heart attack in which an artery is generally completely blocked by blood clot for sufficient time causing heart muscle damage.

The FDA approval is based on the results of the landmark ExTRACT-TIMI 25 trial (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial InfarCtion Treatment, Thrombolysis In Myocardial Infarction - 25 Study), which included more than 20,000 acute STEMI patients and the results of which were published in the April 6, 2006 edition of the New England Journal of Medicine.

The ExTRACT-TIMI 25 study showed that in patients with STEMI treated with fibrinolysis, enoxaparin significantly reduced the rate of death or recurrent infarction at 30 days by 17% vs. unfractionated heparin (UFH) (9.9% vs. 12.0% p