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Savaysa A-Fib Data Led To Conflicting FDA Views On Dose, Population

 
• By Sue Sutter

Reviewers debated whether to approve Daiichi’s oral anticoagulant only for atrial fibrillation patients with renal impairment or a higher-than-tested dose for those with normal renal function. Disagreements over how to handle renal subgroup efficacy findings also led to differences of opinion on the need for a REMS.

Before FDA could approve Daiichi Sankyo Inc.’s Factor Xa inhibitor Savaysa (edoxaban) for stroke risk reduction in atrial fibrillation patients, the agency had to overcome numerous differences of opinion – both internally and among its external advisors – on some unexpected efficacy findings in the pivotal trial.

Agency staff within and across review disciplines were divided on what to do about a significant interaction between edoxaban efficacy...

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