September 29, 2008
FDA Continues to Review Daiichi Sankyo and Lilly’s Prasugrel NDA
Daiichi Sankyo Company and Eli Lilly and Company have confirmed that the FDA did not complete its review for the prasugrel new drug application by the Prescription Drug User Fee Act goal date of September 26, 2008.
The proposed indication for prasugrel is for the treatment of patients with acute coronary syndromes being managed with an artery-opening procedure known as percutaneous coronary intervention.Daiichi Sankyo and Eli Lilly and Company are co-developing prasugrel, an investigational oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, as a potential treatment, initially for patients with acute coronary syndromes who are managed with percutaneous coronary intervention .
Jennifer Stotka, vice president of global regulatory affairs at Lilly, said: "We remain engaged in collaborative and productive discussions with the FDA regarding the details of our application. This is a very large, complex submission, and it should not be surprising that delays occur.
"Daiichi Sankyo and Lilly will not speculate on the timing or what the outcome will be. However, the review is very far along, and we remain optimistic."