Posted by Michael Wonder on 10 Nov 2020
Bayer submits marketing authorization applications for finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes
9 November 2020 - Regulatory submissions based on positive data from Phase 3 FIDELIO-DKD trial recently published in the New England Journal of Medicine.
Bayer today announced the submission of regulatory applications to the U.S. FDA and the EMA seeking approval of finerenone for patients with chronic kidney disease and type 2 diabetes mellitus.
Finerenone is a first in class investigational non-steroidal, selective mineralocorticoid receptor antagonist that demonstrated renal and cardiovascular benefits in patients with CKD and T2D in the Phase 3 FIDELIO-DKD trial.
