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Tuesday, June 18, 2013
Daiichi Sankyo seeks approval for Prasugrel in ACS patients undergoing PCI
today announced that it has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan for the antiplatelet agent prasugrel hydrochloride for the treatment of patients with ischemic heart disease undergoing per cutaneous intervention.
The application is based on the results of a phase 3 trial in Japanese patients with ACS
undergoing PCI (PRASFIT-ACS)
and a phase 3 trial in Japanese patients with coronary artery disease (stable angina or history of previous myocardial infarction, or myocardial infarction) undergoing elective PCI (PRASFIT-Elective).
A Japanese domestic phase 3 trial of prasugrel for patients with ischemic cerebrovascular disease is on-going. This trial is expected to be completed in fiscal year 2014
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