Daiichi Sankyo Co. Ltd. announced that it has received approval from the Ministry of Health, Labor and Welfare in Japan for the antiplatelet agent Efient 3.75mg/5mg Tablets (Prasugrel Hydrochloride) for the treatment of patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI).Efient is an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries Ltd. Efient reduces the incidence of ischemic events in perioperative period of PCI by rapidly reducing platelet aggregation activity.
Daiichi Sankyo submitted the new drug application in Japan based on the results of a Phase 3 trial in Japanese patients with acute coronary syndrome (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).
With approval of the Efient treatment option in Japan, Daiichi Sankyo aims to benefit patients and healthcare professionals by providing a new approach to therapy for ischemic heart disease.
Outside of Japan, based on the co-development by Daiichi Sankyo and Eli Lilly and Co., the European Commission and the FDA granted marketing authorization for Efient/Effient for the prevention of atherothrombotic events in patients with ACS undergoing PCI, in combination with aspirin, in 2009. To date prasugrel has been approved in more than 70 countries worldwide.
Date: March 24, 2014
Source: Daiichi Sankyo
