FDA Needs More Time to Review Heart Drug Prasugrel

The U. S. Food and Drug Administration have said they need more time to review Eli Lilly and Co.'s highly anticipated experimental heart drug. This would be the second time that the drug that is meant to prevent blood clots in patients who have had heart surgeries, has been delayed.

The drug Prasugrel by Indianapolis-based drugmaker Ely Lilli and Co. and its partner, Daiichi Sankyo, would on approval be pitched with Bristol-Meyers Squibb's Plavix, a similar drug with sales of $8.1 billion in 2007. Prasugrel, also known as Effient, will be reviewed by the FDA's Cardiovascular and Renal Drugs Advisory Committee.

In a statement Dr. J. Anthony Ware, Eli Lilly vice president and cardiovascular/acute care platform leader for prasugrel, said, "We have full confidence in the data submitted to the FDA and the overall benefit-risk profile of prasugrel, and we look forward to this next step in potentially bringing an important new alternative to the oral antiplatelet market."

The drug, prasugrel is designed to help prevent blood clots in heart patients who have had artery-opening procedures and was found by a study to prevent more heart attacks and strokes than Plavix did. They also reported that more people taking prasugrel died from bleeding than those taking Plavix.

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