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news.The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted Daiichi Sankyo to market Lixiana (JAN: Edoxaban Tosilate Hydrate, INN:edoxaban) 15 mg and 30 mg tablets, for the prevention of venous thromboembolism after major orthopedic surgery.
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Daiichi Sankyo is developing Edoxaban for several other indications which include stroke prevention in atrial fibrillation (AF) patients, and treatment and prevention of recurrent venous thromboembolism.
Further, Daiichi Sankyo is evaluating the drug in a multinational, randomized, double-blind, Phase III ENGAGE AF-TIMI 48 study, to investigate 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.
Daiichi Sankyo president and CEO Joji Nakayama said they are confident that edoxaban will make a great contribution to VTE prevention after major orthopedic surgery.
Daiichi Sankyo Global R&D Unit head Kazunori Hirokawa 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.