July 11, 2009

FDA gives nod to blood-thinning drug

The blood-thinning drug Effient has been approved to reduce the risk of blood clots in angioplasty patients, U.S. health officials say.

The U.S. Food and Drug Administration approved the tablets Friday, a release from the agency indicated. The drug is made by U.S. manufacturer Eli Lilly and Co. and a Japanese partner, and will compete head-on with the popular blood thinner Plavix, the Indianapolis Star reported.

Angioplasty is a common procedure to unblock clogged coronary arteries. During an angioplasty, a balloon is used to open the artery that has been narrowed by atherosclerotic plaque. Platelets in the blood can clump around the procedure site, causing clots that can lead to heart attack, stroke, and death.

FDA officials said Effient was studied in a 13,608-patient trial comparing it to Plavix (in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty. The drug's labeling will include a boxed warning alerting physicians that the drug can cause significant, sometimes fatal, bleeding.

Les Funtleyder, a drug stock analyst for Miller Tabak & Co., told the Star said he questions whether Effient can hit $1 billion in annual sales, given the looming appearances of generics.