FDA grants priority review to NDA for finerenone to treat patients with chronic kidney disease and type 2 diabetes.- Bayer HealthCare.

Bayer announced that the FDA has accepted its New Drug Application (NDA) and granted Priority Review for finerenone to treat patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This regulatory submission was based on Phase III FIDELIO-DKD trial data, detailed results of which were presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020, and simultaneously published in the New England Journal of Medicine in October 2020. A Priority Review designation means that the FDA’s goal is to take action on a New Drug Application within 6 months of acceptance, compared to 10 months under standard review. Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that demonstrated renal and cardiovascular benefits in patients with CKD and T2D in the Phase III FIDELIO-DKD study. Based on these data, which is part of the largest Phase III clinical trial program to date in CKD and T2D, Bayer has also submitted finerenone for marketing authorization in the EU and other countries worldwide. See- "Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes".- George L. Bakris, M.D., Rajiv Agarwal, M.D., Stefan D. Anker, M.D., Ph.D., Bertram Pitt, M.D., et al.for the FIDELIO-DKD Investigators.-December 3, 2020. N Engl J Med 2020; 383:2219-2229 DOI: 10.1056/NEJMoa2025845.