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FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
Date:2/21/2008

Investigational antiplatelet agent submitted for treatment of patients with

acute coronary syndrome being managed with percutaneous coronary

intervention

TOKYO and INDIANAPOLIS, Feb. 21 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) accepted and designated Priority Review for the New Drug Application for prasugrel, for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI). The NDA for prasugrel was submitted to the agency on Dec. 26, 2007.

A priority designation by the FDA sets the PDUFA (Prescription Drug User Fee Act) goal date. The PDUFA goal for priority applications is to have an action provided for 90 percent of applications within six months. FDA can take three different actions - approved, approvable with further discussion, or not approved.

"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.

"If approved, prasugrel will provide physicians and acute coronary syndrome patients an alternative medicine that may further help reduce the risk of heart attacks," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Ltd.

About prasugrel

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE:

SOURCE Eli Lilly and Company
Copyright©2008 PR Newswire.
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