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)