An FDA advisory panel will review the blood-cloth preventer prasugrel, according to maker Daiichi Sankyo Co.

The U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) scheduled a public hearing to evaluate prasugrel in the first quarter of the coming year, on Feb. 3.

"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," affirmed John Alexander M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.

J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for prasugrel said the company relies on the data submitted to the agency and the benefit-risk profile of the potential blockbuster medicine, and is expecting to bring up “an important new alternative to the oral antiplatelet market."

Developed by Daiichi Sankyo, prasugrel is currently under clinical development in conjunction with Eli Lilly and Company for acute coronary syndrome (ACS) planned for percutaneous coronary intervention (PCI).

ACS, a set of signs and symptoms related to the heart, affects more than 1.4 million people in the U.S. each year.
The investigational agent works by stopping blood cells called platelets from clumping together.

At the beginning of December, a European Medicines Agency committee made positive comments on prasugrel, recommending its approval. The European Commission will be notified of this opinion.