Daiichi Sankyo Launches Anticoagulant LixianaⓇ OD Tablets (orally disintegrating tablets) in Japan

November 29, 2017

Products

For Immediate Release

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

Tokyo, Japan (November 29, 2017)- Daiichi Sankyo Company, Limited (Headquarters：Chuo-ku, Tokyo; hereafter, Daiichi Sankyo) announced today that it has launched its oral anticoagulant Lixiana^Ⓡ OD Tablets 15 mg, 30 mg and 60 mg (generic name: Edoxaban Tosilate Hydrate, date of manufacture and marketing approval: August 16, 2017; date of listing in NHI reimbursement price list in Japan: November 29, 2017) in Japan.

Lixianais a once daily oral anticoagulant that selectively, reversibly and directly inhibits FXa (activated blood coagulation factor X) which is involved in blood coagulation in blood vessels. Lixianahas the 3 indications of prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), treatment and recurrence prevention of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary thromboembolism (PE)], and prevention of VTE after major orthopedic surgery, and is currently widely used in the prevention and treatment of thromboembolism.

Daiichi Sankyo expects the addition of Lixiana OD Tablets, which are designed to be easy to take for elderly patients, to contribute greatly to increasing medication adherence* in patients requiring anticoagulant therapy.

*Medication adherence: the extent to which patients actively follow a medication regimen as prescribed by their health care providers.

Product Outline

[Launch date: November 29, 2017]

Brand name	Lixiana^Ⓡ OD Tablets 15 mg, 30 mg, 60 mg
Generic name (JAN)	Edoxaban Tosilate Hydrate
Drug price	LixianaOD Tablets 15 mg: 294.20 yen/tablet LixianaOD Tablets 30 mg: 538.40 yen/tablet LixianaOD Tablets 60 mg: 545.60 yen/tablet [Date of listing in NHI reimbursement price list: November 29, 2017]
Indications	・ Prevention of ischemic stroke and systemic embolism in patients with non-valvularatrial fibrillation (NVAF) ・ Treatment and recurrence prevention of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary thromboembolism (PE)] ・ Prevention of VTE after major orthopedic surgery; for following lower limb procedures: Total knee replacement surgery, total hip replacement surgery, hip fracture surgery
Dosage and administration	・ Prevention of ischemic stroke and systemic embolism in patients with NVAF ・ Treatment and recurrence prevention of VTE [DVT and PE] ・ For adults, under normal conditions, the following doses as edoxaban are taken orally once daily: - Body weight up to 60 kg: 30 mg - Body weight over 60 kg: 60 mg Depending on renal function and concomitant medication, decrease dose to 30 mg once daily ・ Prevention of VTE after major orthopedic surgery For adults, under normal conditions, 30 mg as edoxaban is taken orally once daily
Date of manufacture and marketing approval	August 16, 2017
Manufacture and marketing	Daiichi Sankyo Co., Ltd.

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