Posted by Michael Wonder on 12 Jan 2021
U.S. FDA grants priority review to new drug application for finerenone to treat patients with chronic kidney disease and type 2 diabetes mellitus
12 January 2021 - Bayer announced today that the U.S. FDA has accepted its new drug application and granted priority review for finerenone to treat patients with chronic kidney disease and type 2 diabetes mellitus.
This regulatory submission was based on Phase 3 FIDELIO-DKD trial data, detailed results of which were presented at the American Society of Nephrology’s Kidney Week Reimagined 2020, and simultaneously published in the New England Journal of Medicine in October 2020.
