Daiichi Sankyo announced that a New Drug Application (NDA) has been submitted to the FDA for Savaysa (edoxaban) Tablets 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 an investigational, oral, once-daily direct factor Xa-inhibitor.
The NDA submission was based on data from an extensive global clinical trial program that compared treatment with 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.
Edoxaban is currently in Phase 3 clinical development.
For more information call (877) 437-7763 or visit DaiichiSankyo.com.