WHIPPANY, N.J. — Bayer said the U.S. Food and Drug Administration has accepted its supplemental New Drug Application and granted Priority Review for Kerendia as a potential treatment for adults with Type 1 diabetes and chronic kidney disease.
Kerendia, also known as finerenone, is a non-steroidal mineralocorticoid receptor antagonist. If approved for the new use, Bayer said it would become the first mineralocorticoid receptor antagonist indicated for adults with Type 1 diabetes and chronic kidney disease.
The application is supported by the Phase III FINE-ONE trial, which showed Kerendia significantly reduced urine albumin-to-creatinine ratio over six months compared with placebo when used alongside standard care in adults with Type 1 diabetes and chronic kidney disease. Bayer said the filing was also supported by pooled Phase III data from the FIDELIO-DKD and FIGARO-DKD trials in adults with chronic kidney disease associated with Type 2 diabetes.
Urine albumin-to-creatinine ratio is an important marker of cardiovascular risk and kidney disease progression. Bayer said about 20% to 30% of people in the U.S. with Type 1 diabetes also have chronic kidney disease, putting them at higher risk of cardiovascular events and kidney failure.
“The FDA’s acceptance of this application underscores the clinical importance of our ongoing program for KERENDIA, and growing evidence base, across broad patient populations in cardiovascular and kidney diseases,” said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “With five Phase III trials now having achieved their primary endpoints — including FINE-ONE, which forms the basis of this submission — we’re proud that this milestone brings us one step closer to potentially addressing unmet needs among people living with type 1 diabetes and chronic kidney disease.”
FINE-ONE is a pivotal, global, randomized, double-blind, multicenter Phase III study that enrolled 242 adults with Type 1 diabetes and chronic kidney disease. The study evaluated whether adding finerenone, given once daily at 10 or 20 milligrams, to standard care was superior to placebo in reducing urine albumin-to-creatinine ratio over six months.
The trial met its primary endpoint, with Kerendia significantly reducing urine albumin-to-creatinine ratio compared with placebo. Bayer said safety and tolerability were largely consistent with the existing evidence for Kerendia in people with Type 2 diabetes and chronic kidney disease.
Treatment-emergent adverse events occurred in 47.1% of patients treated with finerenone and 49.2% of those receiving placebo. Serious treatment-emergent adverse events occurred in 11.8% of patients receiving finerenone and 11.5% of those receiving placebo.
Hyperkalemia, or elevated potassium levels, was reported more frequently with finerenone, occurring in 10.1% of patients compared with 3.3% in the placebo group. Treatment discontinuation due to hyperkalemia occurred in 1.7% of patients receiving finerenone and none of those receiving placebo.
Kerendia has been approved since 2021 to reduce the risk of cardiovascular death, hospitalization for heart failure, non-fatal myocardial infarction, sustained decline in kidney function and end-stage kidney disease in adults with chronic kidney disease associated with Type 2 diabetes.
In July 2025, Kerendia also received FDA approval to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction of at least 40%.
