The launching of the drug is backed by the Japanese Ministry of Health, Labor and Welfare’s (MHLW) approval for edoxaban 15mg and 30mg tablets in April 2011.
The MHLW approval was given on the basis of positive results from several clinical trials evaluating Edoxaban as a prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture surgery.
Currently, the company is evaluating Edoxaban in a double-blind, randomized, multinational trial as a preventive measure of stroke and systemic embolic events in patients with AF.
Daiichi Sankyo president and CEO Joji Nakayama said Edoxaban demonstrates solid efficacy in clinical trials (2, 3) in this population of patients.
"Its predictable pharmacokinetic and pharmacodynamic profile allows for a convenient, once-daily dosing," Nakayama said.