Daiichi Sankyo, Lilly Submit NDA for Antiplatelet Drug

Daiichi Sankyo and Eli Lilly have submitted a NDA to the FDA for prasugrel, 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. If approved, the drug will be marketed as Effient in the U.S. It is seen as a key competitor for Plavix, the antiplatelet drug marketed by Sanofi-Aventis and Bristol-Myers Squibb.
   
The NDA is based on data from several trials evaluating the safety and efficacy of prasugrel compared with Plavix in reducing ischemic events such as non-fatal heart attack, non-fatal stroke and cardiovascular death in 13,608 patients. In the study, treatment with prasugrel resulted in a 19% relative risk reduction compared with Plavix in all ACS patients, a 52% reduction compared with Plavix in stent thrombosis, and a 30% relative risk reduction compared to Plavix in a subset of patients with diabetes. The combined endpoint of the study included non-fatal heart attack, non-fatal stroke, or cardiovascular death.