Tokyo, Japan and Indianapolis, IN - Anyone who spent Friday awaiting the much-anticipated FDA decision on prasugrel got some unexpected news: in a brief press statement released by Eli Lilly and Daiichi Sankyo right at the end of the day, the companies confirmed that the FDA would be missing its September 26 deadline in order to continue its review of the drug.

Prasugrel, which is expected to be the first real competitor to clopidogrel, is awaiting approval for the treatment of ACS patients who are managed with PCI. The approval application, which was filed in January of this year, was given priority status, with the initial deadline for a decision being back in June. But as heartwire previously reported, the FDA announced June 26 that it would be postponing a decision for three months, in order to review additional analyses it has requested from the sponsors. Today marks the three-month mark but brought no closure for the company or for market-watchers who had expected a decision.

In the press statement, Dr Jennifer Stotka, VP for global regulatory affairs at Lilly, said that it "should not be surprising" that delays occur with such a "very large, complex submission."

"Daiichi Sankyo and Lilly will not speculate on the timing or what the outcome will be," she stated. "However, the review is very far along, and we remain optimistic."

As previously reported by heartwire, prasugrel's approval application is based on the TRITON-TIMI 38 trial, which showed significantly reduced ischemic events compared with clopidogrel, but at the expense of an increase in major bleeding in ACS patients scheduled for PCI.