Daiichi Sankyo submits first NDA for oral factor Xa inhibitor, edoxaban, in Japan

Japanese drug major Daiichi Sankyo has submitted a New Drug Application to the domestic Ministry of Health, Labor and Welfare seeking approval of the anticoagulant edoxaban, for the prevention of venous thromboembolism (VTE) after major orthopedic surgery.

Edoxaban, being developed solely by Daiichi Sankyo, is an oral anticoagulant that directly and specifically inhibits Factor Xa, a clotting factor in the blood. Results from pivotal Phase III studies showed 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.

"Upon approval, we believe that edoxaban, with its simple once-daily oral dosing, will be a significant improvement for patients undergoing orthopedic surgery in Japan," said Kazunori Hirokawa, head of the drugmaker's R&D Division.