FDA Panel Votes in Favor of Edoxaban Approval

After an FDA advisory panel previously called for limited use of edoxaban for atrial fibrillation (AF), the panel ultimately voted in favor of edoxaban for the prevention of stroke and non–central-nervous-system systemic embolism in patients with nonvalvular AF. The FDA is expected to make a final decision in the next few months, and if approved, this would be the fourth novel anticoagulant for the treatment of AF.

The panel analyzed data from the ENGAGE AF-TIMI 48 [Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation—Thrombolysis in Myocardial Infarction 48] trial. The large, event-driven study included 21,105 patients with nonvalvular AF. Once-daily therapy with edoxaban at 2 different doses—30 mg and 60 mg—was noninferior to warfarin for preventing stroke or systemic embolism in patients with nonvalvular AF, according to the study’s results. Both doses of edoxaban were associated with significantly less major bleeding than the vitamin-K antagonist used in the trial.

During the first review of edoxaban, an issue that prompted concerns was related to subgroup analysis from the ENGAGE AF trial. In the study, an analysis stratified by renal function showed that patients with a creatinine clearance >80 mL/min did not fare as well on treatment as those with abnormal renal function.

Edoxaban, a factor Xa inhibitor, is manufactured by Daiichi Sankyo.—Kerri Fitzgerald