Daiichi Sankyo Wins Approval In Japan For Efient
Daiichi Sankyo Company, Ltd. announced that it has won approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for its antiplatelet agent Efient 3.75mg/5mg tablets (Prasugrel Hydrochloride) for the treatment of patients with ischemic heart disease undergoing PCI 1.
Efient is an oral antiplatelet agent discovered and developed by Daiichi Sankyo in collaboration with its Japanese research partner, Ube Industries, Ltd. The drug has been proven to reduce the incidence of ischemic events in perioperative period of PCI through rapid reduction of platelet aggregation activity. The approval for Efient was based on the positive results from a Phase III trial in Japanese patients with ACS 2 undergoing PCI (PRASFIT-ACS 3) together with 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 4).
Prasugrel is indicated for ischemic cardiac diseases, which demand percutaneous coronary intervention (PCI). These include acute coronary syndromes (Unstable angina, Non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction), stable angina, and old myocardial infarction.
Acute coronary syndrome is often manifested in heart attack and unstable angina. These occur when the arteries become narrowed or clogged due to cholesterol and fat deposits. The plaque is also susceptible to eruption, leading to a potentially life threatening blood clot that can travel to the heart and result in ACS5.
“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,” the company said in its press release. The drug has also received approval outside of Japan from the FDA and European Commission for marketing authorization based on the co-development of Daiichi Sankyo and Eli Lilly & Co. Efient/Effient was approved in 2009 for the prevention of atherothrombotic events in patients with ACS undergoing PCI, combined with aspirin. Prasugrel has been approved in over 70 countries around the world to date.