Lovenox Approved for Acute STEMI Patients
May 21, 2007 — Sanofi-aventis has announced that the 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).
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 percent vs. unfractionated heparin (UFH) (9.9 percent vs. 12.0 percent 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 hemorrhage) at 30 days were 2.1 percent in the enoxaparin group and 1.4 percent in the UFH group (p<0.001). The 30-day rate of the composite endpoint of death, myocardial nonfatal re-infarction or nonfatal intracranial hemorrhage (a measure of net clinical benefit) was significantly lower in the enoxaparin group as compared to the unfractionated heparin group (10.1 percent vs. 12.2 percent, 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)."
For more information visit www.sanofi-aventis.us.