Daiichi Sankyo launches Lixiana ® (edoxabán) in Japan for the prevention of venous thromboembolism after major orthopedic surgery

Tokyo, 2011-August Daiichi Sankyo Co. Ltd. is pleased to announce the launch in Japan of Lixiana ® (edoxabán). The arrival on the market of the medicinal product takes place after the approval of commercialization of the Ministry of health, labour and welfare Japanese for submissions of edoxabán in tablets of 15 mg and 30 mg, which took place in April of 20111, and represents the first time in edoxabán is placed at the disposal of patients.

Edoxabán is an oral anticoagulant of daily single notes that specific, reversible and directly inhibits the Xa clotting factor. The adoption of marketing has been based on the results of clinical studies on edoxabán for the prevention of venous thromboembolism in patients following total hip or knee arthroplasty or hip fracture surgery.

Japan release is the world debut of this drug, which is great news for all patients who require prevention against venous thromboembolism after major orthopedic surgery ”, says Joji Nakayama, Chairman and CEO of Daiichi Sankyo, adds: Edoxabán has shown a solid clinical efficacy in the estudios2(3) in this type of patient. In addition, its predictable pharmacokinetic and pharmacodynamic profile allows his administration through a convenient single daily dose ”.

Edoxabán clinical development programme includes various indications which include the prevention of stroke in patients with atrial fibrillation and the treatment and prevention of recurrent venous thromboembolism.

Two studies phase III on edoxabán have currently being developed. The first of these is ENGAGE AF-TIMI 484, a multinational trial, randomized and blind that analyzes the efficacy and safety of the medicinal product in the prevention of stroke and events systemic Embolic in patients with atrial fibrillation. Research involves more than 21,000 patients with atrial fibrillation from 46 countries, which makes it the largest study for this indication worldwide to date. On the other hand, Daiichi Sankyo is completing the recruitment of patients for study HOKUSAI VTE5, another test phase III multinational, randomized and double blind. He participate in 7,500 patients of 450 centres representatives of 40 countries around the world, so it is also the study with greater number of patients to date on treatment and prevention of recurrent venous thromboembolism.

About venous thromboembolism

Venous thromboembolism refers to the generation of clots and subsequent blockage of a vein or pulmonary artery. Deep venous thrombosis and pulmonary embolism are types of venous thromboembolism. Venous thrombosis is the formation of a blood clot in the deep veins of the legs and the pelvis. Pulmonary embolism is caused when a clot reaches the lungs and is housed in the pulmonary arteries.

About edoxabán

Edoxabán is an oral anticoagulant of daily unique decision-making which directly inhibits factor Xa, a relevant factor in the process of blood clotting. Edoxabán is currently available only in Japan for the prevention of venous thromboembolism in patients following total hip or knee arthroplasty or fracture of cadera1 surgery. Daiichi Sankyo continues the development of edoxabán at the global level as a potential new treatment for the prevention of stroke in patients with atrial fibrillation and the treatment and prevention of recurrent venous thromboembolism. Daiichi Sankyo has more than 25 years of experience in research of inhibition of factor Xa and was the first company to study this type of molecules in humans.

About Daiichi Sankyo

Daiichi Sankyo group is dedicated to the research and supply of innovative pharmaceutical products, both in mature markets as emerging, they face various medical needs of patients who are not yet covered. The company was created in 2005 through the merger of two companies of Japanese tradition and Daiichi Sankyo. Daiichi Sankyo is one of the 20 leading pharmaceutical companies in the world. In addition to the maintenance of its drugs for hypertension, Hyperlipidemia, and bacterial infections, the group is focused on the development of treatments for disorders thrombotic research in Oncology as well as new therapies in the cardiovascular area and metabolism. On the other hand, Daiichi Sankyo group has created a hybrid business model , which responds to the diversity of the market and customer seeking to optimize the opportunities for growth in the entire value chain.

The company’s global headquarters is in Tokyo. Its European base, Daiichi Sankyo Europe, is in Munich and has subsidiaries in 12 European countries as well as a plant of global manufacturing in Pfaffenhofen (Germany).