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Biotech / Medical : Biotech News
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From: Doc Bones10/20/2008 6:29:54 AM
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Lilly, Daiichi-Sankyo Await Heart Drug's Approval

By KEVIN KINGSBURY
OCTOBER 17, 2008, 7:56 A.M. ET

Eli Lilly & Co. and Japan's Daiichi-Sankyo Co. said they haven't received any word from the U.S. Food and Drug Administration about the status of their experimental heart drug prasugral.

The promising but potentially risky anti-clotting agent is awaiting FDA approval. A review due to be completed last month by the agency is still unfinished.

The companies put out a statement saying they haven't been told of any FDA actions or decisions "in response to recent media speculation" about the drug's status. The firms added talks with the agency have been continuing.

Prasugrel -- which would be sold under the Effient brand name -- is designed to prevent heart attacks and strokes in heart-disease patients who are undergoing an artery-opening procedure. The companies submitted a new-drug application in December.

The fate of prasugrel is important to Lilly because some of the company's best-selling drugs are scheduled to lose patent protection and become exposed to generic competition within the next several years.

Prasugrel's future also has implications for Bristol-Myers Squibb Co. and Sanofi-Aventis, which comarket Plavix, the leader of the anticlotting drug market with $7.3 billion in global sales last year. Prasugrel would likely eat into those sales, though it might take a while to make a big dent because the proposed initial use of prasugrel is narrower than the approved uses for Plavix.

—Peter Loftus contributed to this article

online.wsj.com
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