Edoxaban approved in the European Union

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The European Commission has granted marketing authorisation for Daiichi Sankyo’s edoxaban (Lixiana), an oral, once-daily selective factor Xa-inhibitor for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack, as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism, and prevention of recurrent DVT and pulmonary embolism in adults.

“Atrial fibrillation-related stroke as well as DVT and pulmonary embolism create a significant societal and economic health burden. We welcome the European Commission’s approval of Lixiana, which means physicians and patients may benefit from a new treatment option to effectively manage these debilitating and life-threatening conditions,” says Jan van Ruymbeke, chief executive officer, Daiichi Sankyo Europe. “Once-daily Lixiana offers the unique combination of an easy-to-use oral anticoagulant with proven efficacy across a broad range of patients and a better bleeding profile compared to well-managed warfarin.”

The European Commission approval is based on two phase 3 clinical trials, ENGAGE AF-TIMI 48 and Hokusai-VTE, which compared treatment with once-daily edoxaban to warfarin, a current standard of care for stroke prevention in patients with atrial fibrillation or for the treatment and prevention of VTE. These studies represent the largest single comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively.

In the ENGAGE AF-TIMI 48 study, once-daily edoxaban showed comparable efficacy (stroke) to warfarin (1.18% vs 1.50% per year, edoxaban 60mg vs warfarin respectively; hazard ratio 0.79; 97.5% confidence interval 0.63–0.99, p<0.001) and superior safety, significantly reducing major bleeding (2.75% vs. 3.43% per year, edoxaban 60mg vs. warfarin respectively; hazard ratio 0.80; 95% confidence interval 0.71–0.91, p<0.001), in a broad range of patients with non-valvular atrial fibrillation.

The Hokusai-VTE study demonstrated that Lixiana effectively reduces symptomatic recurrent VTE, including DVT and fatal and non-fatal pulmonary embolism risk across a broad range of patients (3.2% vs. 3.5% of patients, edoxaban 60mg vs. warfarin respectively; hazard ratio 0.89; 95% confidence interval 0.70–1.13, p<0.001). Edoxaban also showed a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively; hazard ratio 0.81; 95% confidence interval 0.71–0.94, p=0.004).

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