FDA Grants Priority Review to Finerenone for Chronic Kidney Disease in Adults With Type 1 Diabetes

The FDA has accepted a supplemental new drug application (sNDA) and granted priority review to finerenone (Kerendia; Bayer) for the treatment of adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), Bayer announced in a news release. If approved for this investigational new use, finerenone, a nonsteroidal mineralocorticoid receptor antagonist (MRA), would be the first MRA indicated for adults with T1D and CKD.¹

Understanding the Unmet Need

Approximately 20% to 30% of people in the United States with T1D also have CKD, placing them at increased risk of cardiovascular events and kidney failure. Despite this significant disease burden, therapeutic advances in this space have been limited. Finerenone is the first investigational treatment since the 1990s to show positive results in a phase 3 study for people living with T1D and CKD.^1-3

Finerenone works by selectively and potently blocking mineralocorticoid receptor overactivation in the heart and kidneys, a mechanism distinct from older steroidal MRAs and one that has demonstrated cardiorenal benefit across multiple patient populations in the agent's growing body of clinical evidence.⁴

About the FINE-ONE Trial: Key Findings

The sNDA was supported by the phase 3 FINE-ONE trial (NCT05901831), which showed finerenone significantly reduced urine albumin-to-creatinine ratio (UACR) over 6 months compared with placebo when either is used alongside standard of care for adults with T1D and CKD. The sNDA was also supported by pooled phase 3 data from the FIDELIO-DKD and FIGARO-DKD trials in adult patients with CKD associated with type 2 diabetes (T2D).^2,4,5

FINE-ONE is a pivotal, global, randomized, prospective, double-blind, multicenter phase 3 trial. It enrolled 242 adult participants with the primary objective of demonstrating whether the addition of finerenone, 10 or 20 mg once daily, to standard of care is superior to placebo in reducing UACR over 6 months.²

UACR is an important clinical marker in this patient population. Elevated UACR is strongly associated with cardiovascular risk and kidney disease progression in multiple patient populations, including those with T1D and T2D.^2,4

The trial met its primary end point. Finerenone significantly reduced UACR from baseline over 6 months by approximately 25% compared with placebo in patients with T1D and CKD who received standard of care (95% CI, 0.75 [0.65; 0.87]; P = .0001). These detailed FINE-ONE trial results were presented at the American Society of Nephrology (ASN) Kidney Week 2025 and subsequently published in the New England Journal of Medicine.^2,4

Safety and Tolerability

Safety and tolerability were largely consistent with the existing evidence for finerenone in people with T2D and CKD. The rate of treatment-emergent adverse events (AEs) was 47.1% for those treated with finerenone and 49.2% for placebo. The rate of treatment-emergent serious AEs was 11.8% for finerenone and 11.5% for placebo.^2,4

Hyperkalemia, an AE of special interest, was observed more frequently with finerenone (10.1%) than in placebo (3.3%). The rate of treatment discontinuation due to hyperkalemia was 1.7% and 0%, respectively. Pharmacists dispensing finerenone should counsel patients on the importance of serum potassium monitoring, as current prescribing information advises against initiating the drug when serum potassium exceeds 5 mEq/L.⁶

Finerenone's Current Approved Indications

Finerenone already carries 2 FDA-approved indications. Since 2021, it has been approved to reduce the risk of cardiovascular death, hospitalization for heart failure, nonfatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with T2D. In July 2025, finerenone 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 40% or greater.^7,8

A potential approval in T1D-associated CKD would extend the agent's reach to a patient population that has historically had limited pharmacologic options for slowing kidney disease progression beyond renin-angiotensin system blockade.

Drug Interactions and Dispensing Considerations

Pharmacists should be aware of several clinically relevant interaction considerations with finerenone. Concomitant use with strong CYP3A4 inhibitors is contraindicated, and patients should be counseled to avoid grapefruit and grapefruit juice. Concomitant use of moderate or weak CYP3A4 inhibitors warrants serum potassium monitoring, and concomitant use of strong or moderate CYP3A4 inducers should be avoided. Finerenone is also contraindicated in patients with adrenal insufficiency or known hypersensitivity to any component of the product.⁶

Looking Ahead

The priority review designation signals momentum for a potential new treatment option in a population with significant unmet need. With the FDA review now underway, pharmacists and other clinicians who care for patients with T1D and CKD should monitor for an agency decision, which could arrive on an expedited timeline given the priority review designation.

REFERENCES

1. Bayer's KERENDIA® (finerenone) granted priority review of supplemental new drug application by U.S. FDA for treatment of adults with type 1 diabetes and chronic kidney disease. News Release. Bayer. May 21, 2026. Accessed May 22, 2026. https://www.bayer.com/en/us/news-stories/kerendiar-granted-priority-review

2. KERENDIA® (finerenone) meets primary endpoint in phase III clinical trial for adults with type 1 diabetes and chronic kidney disease. News Release. Bayer. November 6, 2025. Accessed May 22, 2026. https://www.bayer.com/en/us/news-stories/kerendia-for-type-1-diabetes-and-chronic-kidney-disease

3. Tuttle KR, Reynolds CL, Kornowske LM, et al. Prevalence and severity of chronic kidney disease in a population with type 1 diabetes from a United States health system: a real-world cohort study. Lancet Reg Health Am. 2025;47:101130. doi:10.1016/j.lana.2025.101130

4. Heerspink HJL, Birkenfeld AL, Cherney DZI, et al. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957. doi:10.1056/NEJMoa251285

5. A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). ClinicalTrials.gov Identifier: NCT0590183. Updated October 21, 2025. Accessed May 22, 2026. https://clinicaltrials.gov/study/NCT05901831

6. Kerendia (finerenone) [prescribing information]. Bayer HealthCare Pharmaceuticals, Inc. Accessed May 22, 2026. https://www.kerendia-us.com/pi

7. Antrim A. Finerenone granted FDA approval to reduce risk of kidney, heart complications in adults with chronic kidney disease, type 2 diabetes. Pharmacy Times. July 12, 2021. Accessed May 22, 2026. https://www.pharmacytimes.com/view/finerenone-granted-fda-approval-to-reduce-risk-of-kidney-heart-complications-in-adults-with-chronic-kidney-disease-type-2-diabetes

8. Halpern L. Finerenone approved by FDA for treatment of adults with heart failure. Pharmacy Times. July 14, 2025. Accessed May 22, 2026. https://www.pharmacytimes.com/view/finerenone-approved-by-fda-for-treatment-of-adults-with-heart-failure