Ministry of Health and Welfare clears oral drug for preventing VTE after major orthopedic surgery.
Daiichi Sankyo received its first marketing approval for the once-daily oral anticoagulant Lixiana® (edoxaban tosilate hydrate), in Japan. The country’s Ministry of Health and Welfare cleared the 15 mg and 30 mg formulations of the direct Factor Xa inhibitor for the prevention of venous thromboembolism after major orthopedic surgery. Clinical trial data has shown benefits of the drug in patients undergoing total knee arthroplasty, total hip arthroplasty, and hip fracture surgery, the firm notes.
Daiichi Sankyo submitted its Japanese approval application for the venous thromboembolism indication back in March 2010. In December the firm reported positive data from the latest Phase III Stars J-V study, which found edoxaban was more effective than enoxaparin in preventing venous thromboembolic events after total hip replacement surgery.
The ongoing global development program for edoxaban covers a number of indications, including stroke prevention in atrial fibrillation, as well as the treatment and prevention of recurrent venous thromboembolism. Ongoing studies include the 21,000 patient international Phase III Engage AF-TMI study, which is evaluating edoxaban in the prevention of stroke and systemic embolic events in patients with atrial fibrillation. The ongoing 7,500 patient Hokusai VTE trial is evaluating the drug for the treatment and prevention of recurrent venous thromboembolism.