Swissmedic approves Lixiana for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation

Swissmedic, the regulatory authority of Switzerland, has granted approval of Daiichi Sankyo’s Lixiana® (edoxaban), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke and systemic embolism (SE) in adult patients with non-valvular atrial fibrillation (NVAF).

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.

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 60 mg demonstrated non-inferiority to warfarin, for the primary efficacy endpoint of occurrence of stroke or SE in patients with NVAF. In addition, once-daily edoxaban 60 mg demonstrated a significant 20% risk reduction of major bleeding in patients with NVAF compared to warfarin.

In the Hokusai-VTE study, once-daily edoxaban 60 mg was non-inferior to warfarin for the primary efficacy endpoint of recurrence of symptomatic VTE. In addition, edoxaban demonstrated a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin.

Switzerland is the first country in Europe where Lixiana has been approved

“Lixiana is an important new anticoagulant for physicians and their patients with NVAF and VTE,” said Glenn Gormley, MD, PhD, 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.”

Atrial fibrillation (AF) is the most common type of heart rhythm disorder, and is associated with substantial morbidity and mortality.  More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years. One in five of all strokes are as a result of AF.

VTE is a major health problem in Europe, with over one million VTE events or deaths per year (France, Germany, Italy, Spain, Sweden, UK), including more than 370,000 VTE-related deaths.

For more information about Daiichi Sankyo, please visit www.daiichisankyo.com.