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Daiichi Sankyo Submits Edoxaban NDA

Daiichi Sankyo has submitted a NDA to the Ministry of Health, Labor and Welfare in Japan seeking approval of edoxaban for the prevention of venous thromboembolism (VTE) after major orthopedic surgery.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Daiichi Sankyo has submitted a NDA to the Ministry of Health, Labor and Welfare in Japan seeking approval of edoxaban for the prevention of venous thromboembolism (VTE) after major orthopedic surgery.

Edoxaban is an oral anticoagulant that specifically inhibits Factor Xa, a clotting factor in the blood. Results from Phase III studies show that once-daily oral administration of edoxaban reduced the incidence of VTE in patients undergoing total knee replacement or total hip replacement, and the non-inferiority to injectable enoxaparin sodium was confirmed.

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