FDA delays review of Eli Lilly’s would-be blockbuster

Shares of Eli Lilly slipped slightly after the FDA announced that it would extend its review of the closely watched anti-clotting drug prasugrel by three months. Daiichi Sankyo and Lilly both believe they have a potential blockbuster on their hands. And the two companies also confirmed plans to launch a late-stage trial that would compare the effectiveness of prasugrel with Plavix, the standard therapy in the field.

Data on prasugrel indicates that the drug can work better than Plavix in preventing clots, but it also increases the risk of bleeding in some patients. For analysts, that kind of safety risk is likely to lead the FDA to limit use of the drug to a more narrowly defined patient population. But the market potential remains large.

- read the release on the delay
- check out the Dow Jones report

Relaed Articles:
Prasugrel gets priority review
Lilly submits prasugrel NDA
Lilly drug outperforms Plavix, but there's a catch
Doubters see big obstacles for Lilly's prasugrel
Lilly pits drug against Plavix in trial

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