Sanofi-Aventis has received approval from US regulators for expanded use of its blockbuster anticoagulant Lovenox as a treatment for severe heart attacks.
The US Food and Drug Administration has approved a supplemental New Drug for Lovenox (enoxaparin) for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI), a severe type of heart attack in which an artery is blocked by a blood clot which causes heart muscle damage.
The FDA approval is based on the results of the ExTRACT-TIMI 25 trial, which included more than 20,000 acute STEMI patients, and showed that for those treated with fibrinolysis, enoxaparin significantly reduced the rate of death or recurrent infarction at 30 days by 17% versus unfractionated heparin. This benefit of enoxaparin, as compared to UFH, was observed both in patients who underwent percutaneous coronary intervention within 30 days after randomisation 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. The 30-day rate of the composite endpoint of death, myocardial nonfatal re-infarction or nonfatal intracranial haemorrhage (which is deemed as a measure of net clinical benefit) was significantly lower in the enoxaparin group as compared to the unfractionated heparin group (10.1% versus 12.2%).
With its new indication, Lovenox can now be used across the full spectrum of acute coronary syndrome conditions including unstable angina or non-ST segment elevation myocardial infarction. Sanofi added that it has also submitted a dossier for the STEMI indication in Europe.
The additional approval is a welcome boost for Lovenox, especially given the pressure the drug is under from generic companies. In February, a California court invalidated the patent on Lovenox in Sanofi’s lawsuit against Amphastar Pharmaceuticals and Teva Pharmaceutical Industries which are seeking approval from the FDA for their copycat version of the drug.