FDA Approval of Blood Thinner Prasugrel Delayed

The Food and Drug Administration has delayed approval of a new blood thinner that has proven more effective than leading drug Plavix, but also is plagued by greater risks of internal bleeding.

The FDA was set to approve Eli Lilly’s blood-thinner Prasugrel in June 2008, but the decision is now a few months off, FDA officials said. Prasugrel is seen as major competition for Plavix, the Bristol-Myers Squibb and Sanofi-Aventis medication that has grown into an $8 billion a year drug widely prescribed by physicians. However, cheaper, generic versions of Plavix are expected to hit pharmacy shelves in 2011.

The FDA asked Eli Lilly to provide “additional analyses” of Prasugrel, company officials said.

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