Daiichi’s Edoxaban A-Fib Claim May Be Limited By Renal Function
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA clinical reviewers recommend approval of the Factor Xa inhibitor only for patients with renal impairment because of adverse efficacy results in patients with normal kidney function; at an Oct. 30 meeting, the cardio-renal advisory committee also will be asked to consider approval at a higher, untested dose.