Daiichi Sankyo, Lilly submit prasugrel drug application with FDA

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Daiichi Sankyo and Eli Lilly have submitted a new drug application (NDA) for investigational antiplatelet drug prasugrel to the FDA.

Prasugrel is an oral antiplatelet agent, initially in development for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI), including coronary stenting, according to the companies.

Company officials said that if the drug is approved for marketing in the United States, the brand name for prasugrel will be Effient.

The NDA is based upon data from several trials, including the TRITON-TIMI 38 clinical trial presented at AHA Scientific Sessions in November 2007, which evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix) in reducing ischemic events such as non-fatal heart attack, non-fatal stroke and cardiovascular death in 13,608 patients.

The study found that in comparison to Plavix is effective in reducing heart risks, but has a higher bleeding rate compared to Plavix for patients who have undergone percutaneous coronary intervention (PCI).

Despite the mixed results of the study, John Alexander, MD, global head of research and development, Daiichi Sankyo remained positive. Alexander said that “given the overall results from TRITON, this submission is particularly meaningful considering that cardiovascular disease is the leading cause of death in the United States and worldwide, killing 16.7 million people each year.”