Daiichi Sankyo receives first market approval in Japan for Lixiana (edoxaban)

TOKYO—Daiichi Sankyo Co. announced April 22 that the company hasreceived its first marketing approval for Lixiana (edoxaban) 15 mg and 30 mg tablets, by the Ministryof Health, Labor and Welfare in Japan.

Edoxaban, which is beingdeveloped solely by Daiichi Sankyo, is a once-daily, oral anticoagulantthat specifically, reversibly and directly inhibits the enzyme, FactorXa, a clotting factor in the blood. Results from clinical studiessupported the approval of edoxaban for the prevention of venousthromboembolism (VTE) in patients with total knee arthroplasty, totalhip arthroplasty and hip fracture surgery.

Commenting onreceiving the first national marketing authorization for edoxaban, JojiNakayama, president and CEO of Daiichi Sankyo, said, "We are pleased toconfirm that an exciting milestone has been reached, and we areconfident that edoxaban will make a great contribution to VTE preventionafter major orthopedic surgery. Daiichi Sankyo also remains committedto exploring the potential for edoxaban in several other indications,and has a robust global clinical trial program."

The globalclinical development program for edoxaban is focused on severalindications, including stroke prevention in atrial fibrillation (AF)patients, and treatment and prevention of recurrent venousthromboembolism. In the ENGAGE AF-TIMI 48 study, an ongoing,multinational, randomized, double-blind, Phase III study, the efficacyand safety of edoxaban in preventing stroke and systemic embolic eventsin patients with AF are being examined in more than 21,000 patients withAF in 46 countries.

The ENGAGE AF-TIMI 48 study is thelargest trial in this indication to date. Also currently ongoing, theHOKUSAI VTE study is the largest single, double-blind, randomized,multinational Phase III study in the treatment and prevention ofrecurrent VTE, involving approximately 7,500 patients in 450 clinicalsites in approximately 40 countries.

Existing anticoagulantsinclude heparins and vitamin K antagonists. Heparins are injectable,which is an important clinical consideration for patients who needlong-term treatment. Vitamin K antagonists are given orally, but areassociated with numerous drug and food interactions.

Commentingon the future global potential for edoxaban, Kazunori Hirokawa, GlobalHead of R&D Unit, Daiichi Sankyo, said, "Edoxaban has been shown tobe an effective anticoagulant for the prevention of VTE after majororthopedic surgery, with a predictable pharmacokinetic andpharmacodynamic profile, which allows for a convenient, once-dailydosing."