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# Priority for Bayer NDA for Kidney/Diabetes Patients
- URL: https://www.fdaweb.com/priority-for-bayer-nda-for-kidney-diabetes-patients/
- Published: 2021-01-12T12:00:00.000Z
- Updated: 2026-09-14T16:42:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148425

FDA has accepted for priority review a Bayer NDA for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and Type 2 diabetes. The submission was based on data from the Phase 3 FIDELIO-DKD trial, which were published in the 10/23/2020 [*New England Journal of Medicine*](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2025845&esheet=52358378&newsitemid=20210112005050&lan=en-US&anchor=New+England+Journal+of+Medicine&index=2&md5=7ef570ab44d9166305c804fd0a6b20ea&ref=fdaweb.com). Finerenone is described by Bayer as a potential first-in-class investigational, non-steroidal, selective mineralocorticoid receptor antagonist that has demonstrated positive kidney and cardiovascular outcomes in patients with CKD and Type 2 diabetes. “Mineralocorticoid receptor overactivation is a driver of kidney and cardiovascular damage through inflammatory and fibrotic processes,” it says.