TOKYO, April 22, 2011 /PRNewswire/ — Daiichi Sankyo Company,
Limited (hereafter, Daiichi Sankyo), announced today 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. 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.(1)
The ENGAGE AF-TIMI 48 study is the largest trial in this
indication to date. Also currently ongoing, the HOKUSAI VTE study
is the largest single, double-blind, randomized, multinational
Phase III study in the treatment and prevention of recurre
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