Paris, France - The FDA has approved enoxaparin (Lovenox) for treatment of acute ST-segment elevation MI, Sanofi-Aventis announced today. The approval was made on the basis of the EXTRACT-TIMI 25 trial, in which enoxaparin reduced the rate of recurrent MI or death in patients receiving either thrombolysis or PCI.

As previously reported by heartwire, EXTRACT-TIMI 25 enrolled more than 20 000 STEMI patients scheduled to undergo fibrinolysis. Patients randomized to enoxaparin experienced significantly less death/MI, driven primarily by a 33% reduction in nonfatal MI, as compared with patients randomized to unfractionated heparin. Rates of major bleeding were higher in the enoxaparin group, however. The study results were published in the New England Journal of Medicine [2].

The drug is already approved in the US for preventing ischemic complications of unstable angina and non-Q-wave MI and to prevent and treat deep vein thrombosis.