FDA advisory panel to review Lilly, Daiichi's blood clotting drug
POSTED January 1, 2009 - 15:22 | POSTED BY Neelam Goswami
Last edited by Harpreet Bhagrath on January 1, 2009 - 15:45
New York, United States, January 1: An experimental heart drug by two global pharmaceutical companies, Eli Lilly and Co. and Daiichi Sankyo Co., Ltd., will be reviewed by a US Food and Drug Administration advisory panel next month, the companies said Wednesday.
Lilly and Daiichi confirmed Wednesday that FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review their blood-clot preventer prasugrel during an advisory committee hearing on Feb. 3, 2009.
The blood thinner prasugrel, a potential blockbuster which is plagued by regulatory delays, will be marketed as Effient in the U.S. if approved.
"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’s vice president and cardiovascular/acute care platform leader for prasugrel.
Indianapolis, Indiana-based Eli Lilly and Japanese drug maker Daiichi Sankyo said they will have further discussions with the FDA in preparation for the advisory committee meeting.
Although FDA is not bound to follow its advisory panel's recommendations, it generally follows their guidance. The agency makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee.
"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, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company Limited.
Prasugrel is an investigational antiplatelet agent for patients with acute coronary syndrome (ACS), which is comprised of heart attacks and unstable angina or chest pain and affects more than 1.4 million people in the United States every year.
Developed by Daiichi Sankyo and its Japanese research partner Ube Industries Ltd., this investigational oral antiplatelet agent Prasugrel falls in the same chemical class as Plavix (clopidogrel), a blockbuster drug sold by Bristol-Myers Squibb (BMY) and Sanofi Aventis, and works by the same mechanism.
