FDA calls in experts for prasugrel review

The US Food and Drug Administration has called on its Cardiovascular and Renal Drugs Advisory Committee to aid in the review of US drug major Eli  Lilly and Japan's Daiichi Sankyo's potential blockbuster blood-thinner  prasugrel.

The CRDAC will review the drug during an advisory hearing on February 3.  Last year (Marketletter October 6, 2008), the FDA delayed the agent's  approval for a second time, taking the action date beyond the September  26 deadline the agency had set itself, with some speculating a decision  might not be reached until March of this year.

"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 Lilly vice president Anthony Ware.