FDA committee recommends approval of Savaysa for Stroke Prevention (AF)-Daiichi Sankyo

The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily Savaysa (edoxaban) 60 mg dosing regimen, from Daiichi Sankyo, for the reduction in Risk of Stroke and Systemic Embolic Events (SEE) in patients with non-valvular Atrial Fibrillation (NVAF). The recommendations were provided after review of the ENGAGE AF-TIMI 48 study results, which were previously communicated at the 2013 American Heart Association Scientific Sessions. The data demonstrated that once-daily edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the reduction in risk of stroke and SEE in patients with NVAF, and demonstrated significantly less major bleeding compared to warfarin, achieving superiority for the principal safety endpoint of major bleeding.

Daiichi Sankyo is currently seeking approval from the FDA for the 60 mg dosing regimen of edoxaban (with a dose reduction to 30 mg for patients with known factors such as renal impairment, low body weight or concomitant use of certain P-glycoprotein inhibitors that can potentially increase the risk of bleeding due to expected higher edoxaban exposure) for the reduction in risk of stroke and SEE in patients with NVAF.