OCT 30 CRDAC

Results Wire: US FDA Advisory Committee Supports Daiichi Sankyo’s Savaysa (Edoxaban) for the Prevention of Stroke in Patients With Atrial Fibrillation, But Is Split On Dosing Recommendations – OCT 30, 2014 (CRDAC)

On Thursday, October 30, 2014, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported, by a vote of 9-Yes to 1-No, with no abstentions, the safety and efficacy of Savaysa (edoxaban tablets), submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

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