Daiichi Sankyo Reports Data Showing Edoxaban On Par With Warfarin
Daiichi Sankyo Co. Ltd. reported late breaking data from recent analysis showing its investigational drug edoxaban was comparable to warfarin for the prevention of stroke or systemic embolic events in VAF patients as well as prophylaxis of VTE.
The findings were from two pre-specified subgroup analyses of East Asian patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) who participated in two Phase 3 edoxaban studies. Data from the two subgroup analyses of 1,943 East Asian patients (from Japan, China, Korea and Taiwan) enrolled in the ENGAGE AF-TIMI 48 study and 1,101 East Asian patients enrolled in the Hokusai-VTE study were consistent with the results from the global study populations.
The ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation) was a phase 3, randomized, double-blind, double-dummy, three-arm, global clinical trial evaluating once-daily edoxaban against warfarin treatment in 21,105 patients with NVAF at moderate-to-high risk of thromboembolic events at 1,393 centers in 46 countries.
Glenn Gormley, senior executive officer and global head of research and development at Daiichi Sankyo Co. Ltd., and president and CEO of Daiichi Sankyo Inc. in the United States, said “The ENGAGE AF-TIMI 48 and Hokusai-VTE trials enrolled large numbers of patients from all regions of the world to advance the understanding of how edoxaban works in a heterogeneous group of patients. The findings from these subgroup analyses further our understanding of edoxaban in East Asian populations, and were consistent with the global patient populations studied.”
Findings from the subgroup analyses were consistent with the full study populations for the principal safety outcomes in both studies, the company said. Daiichi Sankyo presented the data at the Japanese Circulation Society 2014 Annual Scientific Meeting held at Tokyo, Japan.
The company has filed for approval of once daily edoxaban in Japan and in the U.S. for non-valvular atrial fibrillation and symptomatic venous thromboembolism.