EMEA panel backs Lilly's prasugrel

Good news for Eli Lilly. While Lilly was holding its breath for a response from the FDA for its experimental drug, prasugrel, the company managed to gain an endorsement from an EMEA advisory panel. The committee's recommendation will go to the European Commission, which usually makes a decision in two to three months, according to partners Lilly and Daiichi Sankyo. 

Prasugrel, which will be marketed under the brand name Effient, is a blood thinner designed to fight clots in heart disease and stroke patients. The much-watched drug has been touted by analysts as a potential blockbuster. Data from a three-year study involving 13,608 patients showed that Lilly's prasugrel outperformed its top competitor, Plavix, but also presented an increased risk of bleeding.

Lilly submitted its application to the FDA last December. The agency gave the NDA priority review [1], which is designed to ensure a decision within 6 months, rather than the typical 10 months. But the FDA has delayed its review twice--in June [2] and again in September.

- view the Eli Lilly/Daiichi Sankyo release [3]
- check out the IndyStar's report [4] for more

Related Articles:
Daiichi, Lilly: still no word on prasugrel [5]
Deadline clock running on Lilly's next big blockbuster [6]
Biopharma sees tougher FDA approval process [7]
Dry spell or parched desert for NME approvals? [8]
2008 NME approvals no better than last year? [9]