FDA approves Kerendia for chronic kidney disease linked to type 1 diabetes

The U.S. Food and Drug Administration has approved Bayer’s Kerendia, also known as finerenone, for adults with chronic kidney disease associated with type 1 diabetes.

The approval makes Kerendia the first FDA approved treatment option in more than 30 years specifically for adults with chronic kidney disease linked to type 1 diabetes.

Finerenone is a selective, non steroidal mineralocorticoid receptor antagonist.

Under the new indication, Kerendia at doses of 10 mg and 20 mg can be used to reduce urinary albumin to creatinine ratio, or UACR, in adults with chronic kidney disease associated with type 1 diabetes.

Lowering UACR is expected to reduce the risk of sustained decline in estimated glomerular filtration rate and progression to end stage kidney disease.

Around 30% of people living with type 1 diabetes in the U.S. develop chronic kidney disease.

These patients face an increased risk of kidney failure and cardiovascular complications, and many remain at risk of disease progression despite receiving recommended treatments for blood glucose and blood pressure management.

Janet McGill, MD, Professor of Medicine in the Division of Endocrinology, Metabolism and Lipid Research at Washington University School of Medicine in St. Louis and Co Chair of the study’s Executive Committee, said patients with chronic kidney disease and type 1 diabetes have had few treatment options aimed at slowing disease progression for more than three decades.

She said approval of Kerendia to reduce UACR provides an additional treatment option for a population with substantial unmet medical need.

Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and a member of Bayer’s Pharmaceuticals Leadership Team, said the U.S. approval represents an important development for people with chronic kidney disease associated with type 1 diabetes.

She said the new indication reflects Bayer’s aim of expanding treatment options for patients living with serious heart and kidney conditions.

The FDA granted Priority Review to Bayer’s supplemental New Drug Application for finerenone in this population in May 2026.

The approval is supported by positive results from the pivotal Phase III FINE ONE study.

In the trial, Kerendia given in addition to standard of care produced a statistically significant 25% reduction from baseline in UACR over six months compared with placebo in adults with chronic kidney disease associated with type 1 diabetes.

Results from FINE ONE were published in the New England Journal of Medicine in March 2026.

The findings had previously been presented in November 2025 as a Featured High Impact Clinical Trial during the opening plenary session of the American Society of Nephrology Kidney Week.

Evidence supporting the application also included pooled analyses from the Phase III FIDELIO DKD and FIGARO DKD studies involving patients with chronic kidney disease associated with type 2 diabetes.

Those analyses indicated that more than 80% of finerenone’s kidney benefit was explained by reductions in UACR.

The latest decision represents the third FDA approved indication for Kerendia in the U.S.

The medicine has been approved since 2021 for adults with chronic kidney disease associated with type 2 diabetes.

In 2025, it was also approved for adults with symptomatic chronic heart failure and a left ventricular ejection fraction of at least 40%.

The latest approval extends its use to adults with chronic kidney disease associated with type 1 diabetes.

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Bayer, cardiorenal, chronic kidney disease, Diabetes, FDA Approval, Kerendia, kidney disease, pharma news, type 1 diabetes