Daiichi Sankyo Files Prasugrel NDA In Japan
Daiichi Sankyo has submitted an NDA to the Ministry of Health, Labour and Welfare in Japan for prasugrel for the treatment of patients with ischaemic heart disease undergoing percutaneous coronary intervention (PCI).
The application is based on the results of a Phase III trial in Japanese patients with acute coronary syndrome undergoing PCI (PRASFIT-ACS [PRASugrel Compared to Clopidogrel For Japanese PatIenTs with ACS Undergoing PCI]) and a Phase III trial in Japanese patients with coronary artery disease (stable angina or history of previous myocardial infarction, or myocardial infarction) undergoing elective PCI (PRASFIT [PRASugrel For Japanese PatIenTs with Coronary Artery Disease Undergoing Elective PCI]-Elective). The results of PRASFIT-Elective study will be announced at the 22nd Annual Meeting of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT 2013) Congress, to be held from 11th to 13th July, in Kobe, Japan.
A Japanese domestic Phase III trial of prasugrel for patients with ischaemic cerebrovascular disease is ongoing. This trial is expected to be completed in fiscal year 2014.