Daiichi Sankyo Company is seeking approval for an oral antiplatelet agent prasugrel hydrochloride to treat ischemic heart diseased patients undergoing percutaneous coronary intervention (PCI) in Japan.
The company has submitted a new drug application to the Ministry of Health, Labour and Welfare in Japan for prasugrel.
Data from phase 3 trial carried out in Japanese patients with acute coronary syndrome undergoing PCI and phase 3 trial in Japanese patients with coronary artery disease undergoing elective PCI are included in the filing.
Expected to complete in fiscal year 2014, the company is presently conducting a phase 3 domestic trial of prasugrel for patients with ischemic cerebrovascular disease in Japan.
Daiichi Sankyo and its Japanese research partner, Ube Industries, have discovered prasugrel that aids in avoiding clumping of blood platelets thereby inhibiting the possibility of developing blockages.
