Lilly and Daiichi Sankyo try to quash prasugrel panel meeting rumours
This article was originally published in Scrip
Executive Summary
Lillyand Daiichi Sankyoare attempting to damp down rumours over the progress of the US NDA for their novel antiplatelet agent prasugrel (Effient). In a joint statement, the companies, which are co-developing the potential blockbuster, say that they have not been notified of any regulatory action for the NDA or of any decision to have an advisory panel to review the drug. Speculation has mounted that the FDAwas contemplating taking the drug to a panel review, following its failure to complete a review of the product by the PDUFA user fee deadline of September 26th.