Daiichi Sankyo announced 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, 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 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, and treatment and prevention of recurrent venous thromboembolism.
Commenting on the future global potential for edoxaban, Kazunori Hirokawa, Global Head of R&D Unit, Daiichi Sankyo, said, “Edoxaban has been shown to be an effective anticoagulant for the prevention of VTE after major orthopedic surgery, with a predictable pharmacokinetic and pharmacodynamic profile, which allows for a convenient, once-daily dosing.”
Release Date: April 22, 2011
Source: Daiichi Sankyo Group