Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This regulatory submission was based on Phase III FIDELIO-DKD trial data, which were recently presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020, and simultaneously published in the October 23, 2020 edition of the New England Journal of Medicine. Finerenone is a potential first-in-class investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that demonstrated positive kidney and cardiovascular outcomes in patients with CKD and T2D in the Phase III FIDELIO-DKD study The FDA grants Priority Review to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. Under a Priority Review designation, the agency’s goal is to take action on a New Drug Application within six months of acceptance, compared to 10 months under standard review.