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news.Daiichi Sankyo Company and Eli Lilly and Company have confirmed that the FDA's Cardiovascular and Renal Drugs Advisory Committee will review prasugrel during an advisory committee hearing on February 3, 2009.
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Prasugrel is an investigational antiplatelet agent for the treatment of patients with acute coronary syndromes who are being managed with an artery-opening procedure known as percutaneous coronary intervention, which is usually followed by the placement of a stent to help keep the artery open.
Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface. Antiplatelet agents prevent platelets from clumping or sticking together, which can result in clogged arteries and may lead to heart attack or stroke.
Advisory committees provide the FDA with independent advice from outside medical experts during the review process. The companies said that they will have further discussions with the FDA in preparation for the advisory committee meeting.
Anthony Ware, Eli Lilly’s 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.