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Daiichi Sankyo's Once-Daily Edoxaban Meets Primary Efficacy Endpoint for Stroke Prevention and Superiority for the Principal Safety Endpoint Compared to Warfarin for Patients with Atrial Fibrillation in a Phase 3 Clinical Trial
Date:11/19/2013

Sankyo, has now yielded positive data for edoxaban in two major diseases, stroke prevention in atrial fibrillation and treatment of acute venous thromboembolism," said Glenn Gormley, MD, PhD, Global Head of Research and Development and Senior Executive Officer, Daiichi Sankyo Company, Ltd. and Executive Chairman of Daiichi Sankyo, Inc. in the United States (US). "Based on the findings from ENGAGE AF-TIMI 48 and Hokusai-VTE, we look forward to submitting New Drug Applications for edoxaban in both indications by the first quarter of 2014 in the US, Japan and Europe."

The annual incidence of hemorrhagic stroke was 0.47% for warfarin compared to 0.26% for edoxaban 60 mg (HR, 0.54; 95% CI, 0.38 to 0.77; p<0.001) and 0.16% for edoxaban 30 mg (HR, 0.33; 95% CI, 0.22 to 0.50; p<0.001). The annual incidence of ischemic stroke was 1.25% for warfarin compared to 1.25% in the edoxaban 60 mg treatment arm (HR, 1.00; 95% CI, 0.83 to 1.19; p=0.97) and 1.77% per year for the edoxaban 30 mg treatment arm (HR, 1.41; 95% CI, 1.19 to 1.67; p<0.001).2

The annual incidence of intracranial hemorrhage was 0.39% for patients in the edoxaban 60 mg treatment arm (HR, 0.47; 95% CI, 0.34 to 0.63; p<0.001) and 0.26% for the edoxaban 30 mg treatment arm (HR, 0.30; 95% CI, 0.21 to 0.43; p<0.001) compared to 0.85% for warfarin. Fatal bleeds occurred at an annual rate of 0.21% in the edoxaban 60 mg treatment arm (HR, 0.55; 95% CI, 0.36 to 0.84; p=0.006) and 0.13% for the edoxaban 30 mg treatment arm (HR, 0.35; 95% CI, 0.21 to 0.57; p<0.001) compared to 0.38% for warfarin.2

Annualized rates for the key secondary composite endpoint of stroke, SEE and cardiovascular death were 4.43% with warfarin, 3.85% with edoxaban 60 mg (p=0.005) and 4.23% with edoxaban 30 mg (p=0.32). Edoxaban was also associated with reduced annualized cardiovascul
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1. Daiichi Sankyos Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence
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3. Daiichi Sankyo ha completato larruolamento dei pazienti per lo studio Hokusai-VTE su Edoxaban, il più ampio trial clinico di fase 3 per il trattamento delle tromboembolie venose ricorrenti
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