The FINANCIAL — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) on April 27 announced that the European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 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) with one or more risk factors.
The CHMP also recommended approval of Lixiana for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. The two related conditions DVT and PE are collectively referred to as venous thromboembolism (VTE).
“The CHMP recommendation to approve once-daily edoxaban for the NVAF and VTE indications is an important milestone for our company,” 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 European regulatory committee has recognised the positive benefit-risk profile of the 60 mg dosing regimen [with a dose reduction to 30 mg in selected patients with creatinine clearance (CrCL) 15-50 mL/min, body weight ≤ 60 kg, or concomitant use of certain P-glycoprotein (P-gp) inhibitors.”
The CHMP opinion to approve once-daily edoxaban for the prevention of stroke and SE in adult patients with NVAF with one or more risk factors and for the treatment and prevention of recurrent VTE (DVT and PE) is based on the data of the phase 3 ENGAGE AF-TIMI 48 and Hokusai-VTE studies, respectively, according to Daiichi Sankyo.
In the ENGAGE AF-TIMI 48 study, once-daily edoxaban 60 mg demonstrated non-inferiority to well-managed 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<0.001). In addition, once-daily edoxaban 60 mg demonstrated a significant 20% risk reduction of major bleeding in patients with NVAF 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 60 mg 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).
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 suffer from AF and this figure is expected to at least double over the next 50 years.5,6 One in five of all strokes is as a result of AF.
VTE is a major cause of morbidity and mortality. VTE is a major health problem in Europe, with more than one million VTE events or deaths per year (France, Germany, Italy, Spain, Sweden, UK), including more than 370,000 VTE-related deaths.