FDA Panel Recommends Approval of Edoxaban for Stroke Prevention

An advisory panel of the U.S. Food and Drug Administration (FDA) has recommended Savaysa (edoxaban) for approval in the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation. The panel voted nine to one in favor of approval, despite disagreement over dosages for different patient populations. While none disputed the main results of the ENGAGE-AF trial, some of the panel members were discouraged by the reported renal function of patients. Given the dosage patients received during the trial, there was concern that 60mg was too low of a dose for patients with normal renal function. Five out of nine who voted to approve the drug supported a 60mg dose for patients with both normal renal function and mild renal impairment. Others would recommend a higher dosage for patients with normal renal function.

While the FDA typically follows the recommendations of its advisory panels, the administration does have the option to not approve the drug.

Clinical Topics: Arrhythmias and Clinical EP, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Atrial Fibrillation, Embolism, Pyridines, Stroke, Thiazoles, United States Food and Drug Administration


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