Daiichi Sankyo Company, Limited and Eli Lilly and Company confirmed that the US Food and Drug Administration (FDA) did not complete its review for the prasugrel new drug application (NDA) 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 (ACS) being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).

"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," said Jennifer Stotka, vice president for Global Regulatory Affairs at Lilly. "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."

"Daiichi Sankyo and Lilly remain confident in the submission package for prasugrel and look forward to bringing this medication to the market for ACS patients who are being managed with PCI," said John Alexander, global head of research and development, Daiichi Sankyo Company, Limited.

Daiichi Sankyo and Eli Lilly are co-developing prasugrel, an investigational oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndromes who are managed with PCI.

A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in 2005 through the merger of two leading Japanese pharmaceutical companies.