TOKYO, July 19, 2011 /PRNewswire/ — Building on its
cardiovascular portfolio, Daiichi Sankyo Company, Limited
(hereafter, Daiichi Sankyo), is proud to announce the launch of
LIXIANA® (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban) in
Japan. This announcement follows the first marketing approval for
edoxaban 15 mg and 30 mg tablets by the Japanese Ministry of
Health, Labor and Welfare in April 2011 (1), and marks the first
time edoxaban is commercially available to patients in any global
market.
Edoxaban 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.
“Today’s launch of edoxaban marks the global debut of the
medication, which is an exciting breakthrough for patients who
require VTE prevention after major orthopedic surgery,” said Joji
Nakayama, president and CEO of Daiichi Sankyo. “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.”
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. Edoxaban is currently being assessed in the Phase
III ENGAGE AF-TIMI 48 study (4), an ongoing, multinational,
randomized, double-blind trial evaluating the efficacy and safety
of edoxaban in preventing stroke and systemic embolic events in
patients with AF. More than 21,000 patients with AF in 46 countries
are being examined, making this the largest trial in this
indication to date. In addition, Daiichi Sankyo is currently
enrolling patients in its HOKUSAI VTE study (5)
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