Daiichi Sankyo Company, Limited and Eli Lilly and Company confirmed that the US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during an advisory committee hearing on February 3, 2009. Prasugrel is an investigational antiplatelet agent for the treatment of patients with acute coronary syndromes (ACS) who are being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), which is usually followed by the placement of a stent to help keep the artery open.
Advisory committees provide the FDA with independent advice from outside medical experts during the review process. The companies will have further discussions with the FDA in preparation for the Advisory Committee Meeting.
"We welcome the opportunity to discuss any and all of the prasugrel data with the advisory committee and the agency, just as we have throughout the ongoing review," said John Alexander, global head of research and development, Daiichi Sankyo Company, Limited.
"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," said J Anthony Ware, Lilly vice president and cardiovascular/acute care platform leader for prasugrel.