Daiichi Sankyo receives first market approval in Japan for LIXIANA®

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced today that the company has received its first marketing approval for LIXIANA® (JAN: Edoxaban Tosilate Hydrate, INN:edoxaban) 15 mg and 30 mg tablets, by the Ministry of Health, La-bor 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. Re-sults from clinical studies supported the approval of edoxaban for the prevention of venous throm-boembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture sur-gery.

Commenting on receiving the first national marketing authorization for edoxaban, Joji Nakayama, President and CEO 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.”

The global clinical development program for edoxaban is focused on several indications, including stroke prevention in atrial fibrillation (AF) patients, as well as treatment and prevention of recurrent VTE. In the ENGAGE AF-TIMI 48 study, an ongoing, multinational, randomized, double blind, phase III study, the efficacy and safety of edoxaban in preventing stroke and systemic embolic events in patients with AF are being examined in more than 21,000 patients in 46 countries.1 The ENGAGE AF-TIMI 48 study is the largest trial in this indication to date. Also currently ongoing, the HOKUSAI VTE study is the largest single, double-blind, randomized, multinational phase III study in the treat-ment and prevention of recurrent VTE, involving approximately 7,500 patients in 450 clinical sites in approximately 40 countries.2

Existing anticoagulants such as heparins and vitamin K antagonists, although effective, have several clinical considerations. Heparins are injectable agents and therefore less suitable for long-term treat-ment. Vitamin K antagonists are given orally, but are associated with numerous drug and food interac-tions.3 Commenting on the future global potential for edoxaban, Kazunori Hirokawa, Global Head of R&D Unit, Daiichi Sankyo, said, “Based on the data we have seen so far, edoxaban has been shown to be an effective anticoagulant with a predictable pharmacokinetic and pharmacodynamic profile, which allows for a convenient, once-daily dosing. The data are encouraging and support the potential for edoxaban in anticoagulation management while being effective against thromboembolic events.”