Daiichi Sankyo Company, Limited has submitted the New Drug Application (NDA) for its investigational, oral, once-daily direct factor Xa-inhibitor SAVAYSATM (edoxaban) Tablets to the U.S. Food and Drug Administration (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.
"The NDA submission in the U.S. is an important milestone in the development of edoxaban and reflects our long-standing commitment to addressing the needs of patients living with cardiovascular diseases, including those living with AF or VTE," said Glenn Gormley, MD, PhD, Senior Executive Officer and Global Head of Research and Development, Daiichi Sankyo Co., Ltd. and President and CEO of Daiichi Sankyo, Inc. in the United States. "If approved, edoxaban may provide a new treatment option for physicians and their patients with these diseases. We look forward to working with the FDA as it conducts its review of edoxaban."
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