FDA again delays prasugrel decision

Analysts were in for a surprise with the news that the FDA is once again delaying any decision on prasugrel [1], a potential blockbuster anti-clotting drug developed by Eli Lilly and Daiichi Sankyo. The agency said last June it would need three extra months to review the drug, and now it says regulators need even more time.

Some of the analysts haven't lost hope, though, saying that absent an agency request for more data, any delay should be relatively short. But J.P. Morgan's Chris Schott has been sounding a cautionary note on that score. The Wall Street Journal, meanwhile, notes that the folks at Sanofi-Aventis and Bristol-Myers can only be ecstatic to hear that Plavix gets another stay on any new competition.

- check out the Lilly and Sankyo release [2]
- read the report [3] from the Wall Street Journal

Related Articles:
Deadline clock running on Lilly's next big blockbuster [4]
FDA delays review of Eli Lilly's would-be blockbuster [5]
Doubters see big obstacles for Lilly's Prasugrel [6]
Lilly drug outperforms Plavix, but there's a catch [7]