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FDA reviewers question advantages of edoxaban

October 29, 2014 4:41 AM UTC

FDA reviewers said the agency normally would issue a complete response for Savaysa edoxaban from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), but will ask FDA's Cardiovascular and Renal Drugs Advisory Committee on Thursday whether the anticoagulant has a path to market.

"Edoxaban has no proven advantages over any of the 3 direct-acting anticoagulants approved for stroke prevention in patients with atrial fibrillation," wrote the reviewers. ...