Daiichi Sankyo files Savaysa at FDA for Stroke Prevention and for VTE

Daiichi Sankyo Company, Limited has announced that the New Drug Application (NDA) for its investigational, oral, once-daily direct factor Xa-inhibitor Savaysa (edoxaban) Tablets has been submitted to the FDA. In the U.S., Daiichi Sankyo is seeking approval for edoxaban for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for the prevention of recurrence of symptomatic venous thromboembolism (VTE). Savaysa is the proposed brand name for edoxaban if approved for marketing in the U.S.

The NDA submission is based on data from an extensive global clinical trial program that compared treatment with once-daily edoxaban to warfarin, a current standard of care for patients with atrial fibrillation (AF) or VTE. The two clinical trials that formed the basis of the submission, ENGAGE AF-TIMI 48 and Hokusai-VTE, are the largest comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively.