FDA approves Lovenox sNDA for STEMI

French drug major Sanofi-Aventis has been granted US Food and Drug Administration approval for the use of its anticoagulant Lovenox (enoxaparin sodium injection) in patients with acute ST-segment elevation myocardial infarction (STEMI). The clearance adds to the list of indications for which the drug has been approved, including non-STEMI MI, deep vein thrombosis and thromboembolic complications in surgery.

Sanofi explained that the FDA's decision is based on data from the ExTRACT-TIMI trial, which demonstrated that Lovenox brought about a reduction in death in STEMI patients at 30 days of 17% compared with unfractioned heparin which reduced the death rates 9.9%. In addition, the composite endpoint of death, myocardial non-fatal re-infarction or non-fatal intracranial hemorrage, was significantly lower in the Lovenox group (10.1% versus 12.2%). The only negative to emerge from the trial was a slight increase in the risk of major bleeding, which was 2.1% in the treatment arm compared with 1.4% in the control cohort.

The firm added that it has submitted the drug for the STEMI indication to regulators in France, Germany, Italy, Spain and the UK.