Daiichi Sankyo updates on PRASFIT-Elective study, NDA filing

Japanese drug major Daiichi Sankyo (TYO: 4568) says that the follow-up period for the Phase III PRASFIT-Elective study has been completed and that anticipated efficacy and safety results for prasugrel (marketed as Effient in collaboration with Eli Lilly) plus aspirin were obtained compared to clopidogrel sulfate plus aspirin in elective patients with stable angina and chronic myocardial infarction undergoing percutaneous coronary intervention (PCI).

The study began in Japan in 2011 and patients received 24-48 weeks of either prasugrel or clopidogrel. The primary endpoint of the study was to evaluate the efficacy of prasugrel on the composite events of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke.

Based on the findings from PRASFIT-Elective and PRASFIT-ACS, Daiichi Sankyo expects to submit a New Drug Application in Japan in the first half of fiscal year 2013. Detailed results of PRASFIT-Elective will be presented at a future medical congress and at the 77th Japanese Circulation Society annual meeting in Pacifico Yokohama, March 16.