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news.Daiichi Sankyo Company and Eli Lilly and Company have submitted a new drug application for prasugrel to the FDA for the treatment of patients with acute coronary syndrome who are managed with percutaneous coronary intervention, including coronary stenting.
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According to the companies, if approved for marketing in the US, the trade name for prasugrel will be Effient.
Eli Lilly said that the new drug application (NDA) is based upon data from several trials, including the landmark triton-TIMI 38 (thrombolysis in myocardial infarction) clinical trial, which evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix/Iscover) in reducing ischemic events such as non-fatal heart attack, non-fatal stroke and cardiovascular death in 13,608 patients.
Anthony Ware, Lilly vice president and cardiovascular/acute care platform leader for prasugrel, said: “We are elated and 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 acute coronary syndrome patients undergoing percutaneous coronary intervention.”