Daiichi Sankyo has announced that Swissmedic, the regulatory authority of Switzerland, has granted approval of Lixiana (edoxaban), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Simultaneously, Lixiana has received marketing authorisation in Switzerland for the treatment of adult patients with venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), following previous treatment with fractionated or unfractionated heparin for five days, as well as for the prevention of recurrent VTE.
“Lixiana is an important new anticoagulant for physicians and their patients with non-valvular atrial fibrillation and VTE,” says Glenn Gormley, senior executive officer and global head of R&D, Daiichi Sankyo Company, limited and executive chairman and president, Daiichi Sankyo, Inc. “The approval of Lixiana in Switzerland marks Daiichi Sankyo’s first opportunity to make once-daily edoxaban available in a European country, and illustrates the company’s commitment to providing new treatment options to patients with cardiovascular diseases with significant unmet needs.”
The approved indications in Switzerland for Lixiana are based on data from the phase 3 ENGAGE AF-TIMI 48 and Hokusai-VTE studies, the largest and longest single comparative global trials of a novel oral anticoagulant in patients with NVAF or acute VTE, involving 21,105 and 8,292 patients, respectively.
In the ENGAGE AF-TIMI 48 study, once-daily edoxaban 60mg demonstrated non-inferiority to warfarin, for the primary efficacy endpoint of occurrence of stroke or systemic embolism in patients with non-valvular atrial fibrillation (1.18% vs. 1.50% per year, respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001). In addition, once-daily edoxaban 60mg demonstrated a significant 20% risk reduction of major bleeding in patients with non-valvular atrial fibrillation compared to warfarin (2.75% vs. 3.43% per year, respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001).
In the Hokusai-VTE study, once-daily edoxaban 60mg was non-inferior to warfarin for the primary efficacy endpoint of recurrence of symptomatic VTE (3.2% vs. 3.5% of patients, respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). In addition, edoxaban demonstrated a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively; HR, 0.81; 95% CI, 0.71 to 0.94, p=0.004).
Edoxaban is currently marketed in Japan and the United States. In the EU and other countries, regulatory review is ongoing.