Daiichi Sankyo gains first approval for VTE drug Lixiana, in Japan

Japanese drug major Daiichi Sankyo (TYO: 4568) has received its first marketing approval for Lixiana (edoxaban tosilate Hydrate, INN: edoxaban) from the Ministry of Health, Labor and Welfare in Japan.

Edoxaban, which is being developed solely by Daiichi Sankyo, is a once-daily oral anticoagulant that specifically, reversibly and directly inhibits the enzyme Factor Xa, a clotting factor in the blood. Results from clinical studies supported the approval of edoxaban for the prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture surgery.

Commenting on receiving the first national marketing authorization for edoxaban, Joji Nakayama, president and chief executive of Daiichi Sankyo, said: “We are pleased to confirm that an exciting milestone has been reached, and we are confident that edoxaban will make a great contribution to VTE prevention after major orthopedic surgery. Daiichi Sankyo also remains committed to exploring the potential for edoxaban in several other indications, and has a robust global clinical trial program.”