Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical

Japanese drug major Daiichi Sankyo (TYO: 4568) has filed a New Drug Application for its investigational, oral, once-daily direct factor Xa-inhibitor Savaysa (edoxaban) tablets with the US Food and Drug Administration.

In the USA, Daiichi Sankyo is seeking clearance for edoxaban – proposed US trade name Savaysa if approved - 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).

The NDA submission, which follows a similar filing in Europe (The Pharma Letter January 8), 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,