Usage of edoxaban can now be recommended for patients with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Marketing authorisation is based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE studies, the largest single comparative global trials of a novel oral anticoagulant in patients with nonvalvular atrial fibrillation or venous thromboembolism, involving 21,105 and 8,292 patients, respectively.
MD of manufacturers Daiichi Sankyo Europe, Jan van Ruymbeke said: "AF-related stroke as well as DVT and PE 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.
"Daiichi Sankyo is committed to bringing innovative medicines to patients who need them. 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."
Atrial fibrillation (AF), a heart rhythm disorder in which the heartbeat is rapid and irregular, affects over six million Europeans. People with AF are at a five-fold increased risk of stroke compared to the general population, with an estimated financial burden of over €38 billion a year. VTE, a condition where a blood clot forms in a vein, also represents a major cause of morbidity and mortality, resulting in over 500,000 deaths in the EU each year.
In the ENGAGE AF-TIMI 48 study, once-daily LIXIANA showed comparable efficacy (stroke or SEs) in comparison to warfarin (1.18% vs. 1.50% per year, LIXIANA 60 mg vs. warfarin respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001) and superior safety, significantly reducing major bleeding (2.75% vs. 3.43% per year, LIXIANA 60 mg vs. warfarin respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001), in a broad range of patients with NVAF.