AsianScientist (Apr. 26, 2011) – Daiichi Sankyo Co. announced on April 22nd that it has received the first marketing approval for LIXIANA® 15 mg and 30 mg tablets by the Ministry of Health, Labor and Welfare in Japan.
Edoxaban (Edoxaban Tosilate Hydrate), 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 support the approval of edoxaban for the prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty, and hip fracture surgery.
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 VTE. For both purposes, patients in approximately 40 countries are being examined in currently ongoing studies.
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 with AF in 46 countries.
Also currently ongoing, is the HOKUSAI VTE study, the largest single, double-blind, randomized, multinational phase III study in the treatment and prevention of recurrent VTE, involving approximately 7,500 patients in 450 clinical sites in approximately 40 countries.
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 treatment. Vitamin K antagonists are given orally, but are associated with numerous drug and food interactions.
Edoxaban has been shown to be an effective anticoagulant with a predictable pharmacokinetic and pharmacodynamic profile, according to Kazunori Hirokawa, Global Head of R&D, Daiichi Sankyo.
This allows for convenient, once-daily dosing and supports the potential for edoxaban in anticoagulation management while being effective against thromboembolic events.
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Source: Daiichi Sankyo.
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