May 27, 2014
Local (JPN)

For Immediate Release

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Corporate Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/

Daiichi Sankyo Launches the Antiplatelet Agent Efient® 3.75mg/5mg Tablets

Tokyo, Japan (May 27, 2014) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has launched the antiplatelet agent Efient® 3.75mg/5mg Tablets in Japan (JAN: Prasugrel Hydrochloride; approval to market: March 24, 2014; NHI drug price listing: May 23, 2014).

 

Efient® is an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Limited. The results of phase 3 clinical trials in Japanese patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI) demonstrated that Efient® reduces the incidence of ischemic events from the perioperative period of PCI by rapidly reducing platelet aggregation activity.

 

Through the launch 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.

 

Based on co-development of the agent outside of Japan by Daiichi Sankyo and Eli Lilly and Company, the European Commission and the US FDA granted marketing authorization for Efient®/Effient® for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing PCI, in combination with aspirin, in 2009. To date, prasugrel has been approved in more than 70 countries worldwide.

 

Product Overview in Japan

 

 Product Name

 Efient® 3.75mg/5mg Tablets

 Generic name  (JAN)

 Prasugrel Hydrochloride

 Price Listing

 Efient® 3.75mg : \282.70 per tablet
 Efient® 5mg : \359.80 per tablet

 Indication

 Prasugrel is indicated for the following ischemic cardiac diseases, which require  percutaneous coronary intervention (PCI):

 ・Acute coronary syndromes (Unstable angina, Non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)

 ・Stable angina, Old myocardial infarction

 Dosage and administration

 Prasugrel should be initiated orally with a single 20-mg loading dose and then continued at a 3.75-mg once daily dose for adults.

 Approval date

 March 24, 2014

 Manufacturing and marketing

 Daiichi Sankyo Company, Limited

 

 

About Acute Coronary Syndrome

Acute coronary syndrome includes heart attacks and unstable angina (chest pain). Myocardial infarction (heart attack) is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot which may partially or totally block the blood supply to portions of the heart, resulting in ACS.