No end in sight for FDA prasugrel decision
In response to recent media speculation regarding the status of prasugrel’s new drug application (NDA), Daiichi Sankyo and Eli Lilly have reiterated that they are in continued discussions with the FDA and have not been notified of any regulatory action for the NDA, or of any decision to have an advisory committee to review prasugrel.

An Oct. 16 report in the Pink Sheet Daily said that the FDA contacted advisory committee experts about a February 2009 panel meeting to discuss the an oral antiplatelet agent.

“The FDA can schedule an Advisory Committee at any time during the review of an application. If one is called, then we will be prepared to participate,” said John Alexander, MD, global head of research and development, the Toyko-based Daiichi.

“We remain confident in the overall benefit-risk profile of prasugrel, and we believe this drug should be approved so that we can bring this valuable treatment option to ACS patients, a population at risk for further cardiovascular events," said Jennifer Stotka, MD, vice president of global regulatory affairs for the Indianapolis-based Lilly.

Last month, the FDA was scheduled to make a decision about prasugrel; however, at that time, the regulatory body failed to approve or disapprove the drug, and also failed to set forth any new timeline.

If approved, it would compete with Sanofi-Aventis and Bristol-Myers Squibb’s Plavix, which loses patent protection in 2011. Plavix had sales of about $7.3 billion last year, according to data from IMS Health.