Daiichi Sankyo and Eli Lilly submit NDA to US FDA for prasugrel; to be sold as Effient

Japanese drugmaker Daiichi Sankyo and US drug major Eli Lilly have submitted a New Drug Application for prasugrel to the US Food and Drug Administration. The agent is an oral antiplatelet drug, initially in development for the treatment of patients with acute coronary syndrome who are managed with percutaneous coronary intervention, including stents.

If approved for marketing in the USA, the trade name for prasugrel will be Effient, the companies noted. J. Ware, Lilly vice president, said: "we feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008. The benefit/risk profile of this compound, in comparison with the current standard of care, has the potential to improve outcomes for ACS patients undergoing PCI."

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