Pharmaprojects R&D Pipeline News Feed
Long awaited submission of US NDA for prasugrel
15 Jan 2008
Daiichi Sankyo and Eli Lilly have submitted an NDA to the US FDA for their antiplatelet therapy, prasugrel. Prasugrel blocks the P2Y12 ADP receptor located on platelets, thereby inhibiting platelet activation. It is indicated for the treatment of acute coronary syndrome (ACS) in patients undergoing percutaneous coronary intervention.
This submission follows data from several clinical trials, including the TRITON-TMI 38 trial assessing the safety and efficacy of prasugrel compared with clopidogrel. Results showed a lower incidence of heart attacks in prasugrel-treated patients, while death from cardiovascular causes was similar in both groups. Prasugrel treatment was associated with higher rates of bleeding.
John Alexander, head of research and development at Daiichi Sankyo said that the NDA submission for prasugrel was "particularly meaningful considering that cardiovascular disease is the leading cause of death in the United States and worldwide".
ACS affects over 1.6 million people per year in the US and Europe, with 450,000 heart attack deaths in the US. If approved in the US, prasugrel will be marketed under the name Effient. A European submission for prasugrel is planned for early 2008.
