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Edoxaban Wins FDA Panel Nod On Approval But Mixed Verdict On Population, Dose

This article was originally published in The Pink Sheet Daily

Executive Summary

Cardio-renal committee votes 9-1 for approval of Daiichi’s anticoagulant for stroke risk reduction in patients with nonvalvular atrial fibrillation, but only five panelists said the currently proposed 60 mg dose should be approved for patients with normal renal function given adverse efficacy results in this subpopulation.

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