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Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee
Date:2/3/2009

TOKYO and INDIANAPOLIS, Feb. 3 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 that prasugrel, an investigational antiplatelet agent, should be approved for the treatment of patients with acute coronary syndromes (ACS) managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), Daiichi Sankyo Company, Limited, (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) announced today.

The Advisory Committee voted unanimously that prasugrel should be approved for the treatment of patients with acute coronary syndromes undergoing PCI. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing new drug applications.

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

"We will continue to work closely with the FDA as the agency moves toward an action on the new drug application for prasugrel," said J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for prasugrel. "It is important for patients to have multiple treatment options, and currently, ACS patients undergoing PCI have few options. Today's vote by the advisory committee members is a positive step for patients."

"Prasugrel represents an important new option for patients with ACS who are managed with PCI," said lead TRITON-TIMI 38 investigator Elliott Antman, M.D., director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital (BWH)
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SOURCE Eli Lilly and Company
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