February 07, 2007
FDA grants priority review to Lovenox for new heart attack indication
Sanofi-Aventis has won FDA priority review for a new indication for its blockbuster blood thinner Lovenox.
The FDA will review Lovenox for treatment of patients suffering acute ST-segment elevation myocardial infarction (STEMI). STEMI is a heart attack in which an artery is generally completely blocked for enough time to cause heart muscle damage. The blockage is caused by blood clot formation in the heart arteries.
Sanofi-Aventis said it also submitted the drug for the new indication in European countries including the UK, Spain, France, Germany and Italy.
Lovenox is currently approved by the FDA for seven indications for the prophylaxis and treatment of thromboembolic disease.
Global sales of Lovenox were at $2.5 billion for 2005.