Savaysa A-Fib Data Led To Conflicting FDA Views On Dose, Population

Before FDA could approve Daiichi Sankyo Inc.’s Factor Xa inhibitor Savaysa (edoxaban) for stroke risk reduction in atrial fibrillation patients, the agency had to overcome numerous differences of opinion – both internally and among its external advisors – on some unexpected efficacy findings in the pivotal trial.

Agency staff within and across review disciplines were divided on what to do about a significant interaction between edoxaban efficacy and renal function in a-fib patients. Specifically, patients with normal...