FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSA™ (edoxaban) 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). Members of the committee also provided their opinions on the use of SAVAYSA.

"We are confident that the outcomes and robustness of the ENGAGE AF-TIMI 48 study fully support the approval in the U.S. of the 60 mg dosing regimen of SAVAYSA for patients with NVAF, with a dose reduction to 30 mg in selected patients," said Glenn Gormley, MD, PhD, Senior Executive Officer and Global Head of R&D, Daiichi Sankyo Company, Limited and Executive Chairman and President, Daiichi Sankyo, Inc. "We will continue to work with the FDA as it completes its review of our New Drug Application for SAVAYSA for the prevention of stroke and SEE in patients with atrial fibrillation."

The FDA regularly seeks the advice of its advisory committees as it reviews New Drug Applications, although it is not bound to follow the recommendations.

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. Daiichi Sankyo is also seeking approval of edoxaban for the treatment and prevention of recurrence of symptomatic venous thromboembolism (VTE) based on the results from the Hokusai-VTE study, which is the single largest comparative trial of a novel oral anticoagulant in this patient population.

SOURCE Daiichi Sankyo Company, Limited