FDA advisory committte encourages FDA approval of blood-thinning drug

2/4/2009

INDIANAPOLIS A Food and Drug Administration advisory committee has recommended approval of an investigational blood-thinning drug from Eli Lilly & Co.

Lilly and development partner Daiichi Sankyo announced Tuesday that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted unanimously to recommend that the FDA approve prasugrel for treating acute coronary syndromes in patients undergoing a surgical procedure called percutaneous coronary intervention.

"We are very proud of the prasugrel data," Daiichi Sankyo global head of research and development John Alexander said in a statement. "Today's scientific exchange set the stage for a potential FDA approval of prasugrem, and the future availability of this significant scientific advancement for the treatment of ACS-PCI patients."

The panel's recommendation was based on a phase 3 clinical trial showing that prasugrel taken with aspirin resulted in a 19% better reduction in death from cardiovascular causes than Sanofi-Aventis' and Bristol-Myers Squibb's Plavix (clopidogrel) taken with aspirin.

Lilly and Daiichi Sankyo have not yet assigned a brand name to prasugrel.

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