sanofi-aventis announced that the Food and Drug Administration (FDA) has approved 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).
Lovenox 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<0.001). This benefit of enoxaparin, as compared to UFH, was observed both in patients who underwent percutaneous coronary intervention within 30 days after randomization or who where treated medically. The rates of major bleeding (including intracranial haemorrhage) at 30 days were 2.1% in the enoxaparin group and 1.4% in the UFH group (p<0.001). The 30 day rate of the composite endpoint of death, myocardial nonfatal re-infarction or nonfatal intracranial haemorrhage (a measure of net clinical benefit) was significantly lower in the enoxaparin group as compared to the unfractionated heparin group (10.1% vs. 12.2%, p<0.001).
"The FDA approval is a significant milestone in the evaluation of treatment options of patients with STEMI," said Elliott Antman, M.D., Senior Investigator TIMI Study Groups, Director, Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital, Professor of Medicine, Harvard Medical School, and lead investigator of the ExTRACT-TIMI 25 study. "With its new indication, enoxaparin is now applicable across the full spectrum of acute coronary syndrome conditions including unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI)."
Sanofi-aventis has also submitted a dossier for the STEMI indication in European countries including France, Germany, UK, Italy and Spain.
Lovenox is a unique chemical entity in a class of antithrombotic agents known as lowmolecular weight heparin (LMWH). The number one selling low-molecular weight heparin in the world, Lovenox is obtained by alkaline degradation of heparin benzyl ester and is about onethird the molecular size of unfractionated heparin. Lovenox is the most widely studied LMWH, with 15 years of use in the treatment of 130 million patients in 96 countries.
Lovenox is approved in the United States for the prophylaxis of ischemic complications of unstable angina and non-Q-wave (non-ST-segment elevation) myocardial infarction when concurrently administered with aspirin and for the prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE); in patients undergoing abdominal surgery who are at risk for thromboembolic complications; in patients undergoing hip replacement surgery (during and following hospitalization), in patients undergoing knee replacement surgery; and in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness; as well as for the inpatient treatment of acute DVT, with or without PE, when administered in conjunction with warfarin sodium and for the outpatient treatment of acute DVT without PE, when administered in conjunction with warfarin sodium.