FDA grants priority review to Lovenox for new heart attack indication

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...