MUNICH, January 22, 2016 /PRNewswire/ --
Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today announced that the German public health agency, The Federal Joint Committee (Gemeinsamer Bundesausschuss - G-BA), has granted an indication of a minor additional benefit for LIXIANA(R) (edoxaban), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF). These findings will help to form the basis for the continued reimbursement for LIXIANA(R) by statutory health insurance providers in Germany. This recognition has been awarded due to improved patient outcomes, noting fewer bleedings including intracranial hemorrhages and major adverse events following treatment with edoxaban compared to warfarin. LIXIANA(R) is the first once-daily novel oral anticoagulant (NOAC), for which the G-BA has recognised an additional benefit.
Oliver Appelhans, Daiichi Sankyo Vice President and European Launch Leader, commented, "The Federal Joint Committee's decision reinforces the value of edoxaban for this at-risk patient population, and is further evidence of the solid clinical foundations upon which the treatment has been approved in countries throughout Europe." He continued, "Daiichi Sankyo is committed to bringing innovative medicines to patients who need them. We're excited that edoxaban is now widely available in Europe and that regulators have consistently recognised its value as a treatment option."
The latest Federal Joint Committee follows full approvals granted by regulators in Scotland, the UK, Switzerland and The Netherlands for indications in prevention of stroke and SE in NVAF.
The Federal Joint Committee's decision is based on data from a large scale Phase III clinical study, ENGAGE AF-TIMI 48, which compared treatment with once-daily edoxaban to warfarin. This study represents one of the largest single comparative trials of a novel oral anticoagulant in this patient population, involving 21,105 patients. In this 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 (1.18% vs. 1.50% per year, respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p