Daiichi Sankyo Launches Direct Oral Factor Xa Inhibitor
Daiichi Sankyo Launches Direct Oral Factor Xa Inhibitor
Daiichi Sankyo Company, Limited recently announced the launch of LIXIANA (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban) in
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 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, 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, the largest single, double-blind, randomized, multinational Phase III study for the treatment and prevention of recurrent VTE, involving approximately 7,500 patients in 450 clinical sites in approximately 40 countries worldwide.
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies.
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