Health
FDA panel recommends approval of anticlotting drug
NEWS IN BRIEF — Posted Feb. 23, 2009
A Food and Drug Administration advisory panel recommended by a 9-0 vote that the agency approve a new drug, prasugrel. The drug is intended to prevent blood clots in people at risk for heart attacks and strokes.
If approved by the FDA, the drug would be in competition with the blood-thinner Plavix, or clopidogrel, the world's second-best-selling drug after the statin drug Lipitor.
The FDA generally follows the advice of its advisory panels.
Although the new drug, which will be marketed as Effient, was said to achieve anticoagulation status more quickly than does Plavix, it also carries a higher risk of bleeding, according to testimony at the Feb. 3 panel hearing.
A head-to-head comparison of Plavix and prasugrel published in the New England Journal of Medicine in 2007, found that the new drug resulted in reduced rates of myocardial infarction but it increased the risk of life-threatening bleeding.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2009/02/23/hlbf0223.htm.
