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

If approved for this investigational new use, KERENDIA^® (finerenone), a non-steroidal mineralocorticoid antagonist (MRA), would be the first MRA indicated for adults with type 1 diabetes and chronic kidney disease.

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer

Summary

Bayer announced today that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for KERENDIA^® (finerenone), which is being investigated for the treatment of adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).

Key Facts

• The sNDA was supported by the Phase III FINE-ONE trial, which showed KERENDIA significantly reduced urine albumin-to-creatinine ratio (UACR) over six months compared with placebo when either are used alongside standard of care for adults with T1D and CKD.¹
  • The sNDA was also supported by pooled Phase III data from the FIDELIO-DKD and FIGARO-DKD trials in adult patients with CKD associated with type 2 diabetes (T2D).
• UACR is an important marker of cardiovascular risk and kidney disease progression.
• Approximately 20-30% of people in the U.S. with T1D also have CKD,^2,3 which puts them at risk of cardiovascular events and kidney failure. ¹
• The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.⁴
• KERENDIA is currently approved by the FDA for use in adults with CKD associated with T2D, as well as adults with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.⁵

Why This sNDA Acceptance Matters

If approved, KERENDIA, a non-steroidal mineralocorticoid receptor antagonist (MRA), would be the first MRA indicated for adults with T1D and CKD.

“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 the first Phase III study since the 1990s to show positive results for patients with T1D and CKD.

KERENDIA’s Currently Approved Indications

Since 2021, KERENDIA has been approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with T2D.

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 HF LVEF ≥40%.⁶

FINE-ONE Clinical Trial Results

FINE-ONE (NCT05901831) is a pivotal, global, randomized, prospective, double-blind, multicenter, Phase III study in people with T1D and CKD. FINE-ONE enrolled 242 adult participants with the primary objective to demonstrate whether the addition of finerenone, 10 or 20 mg once daily, to standard of care is superior to placebo in reducing UACR over six months.

The results showed:

• KERENDIA significantly reduced UACR compared to placebo in patients with T1D and CKD on standard of care over the six-month study period (LS mean change = 0.75; 95% CI [0.65 to 0.87]; P<0.001). ¹
• Safety and tolerability were largely consistent with the existing evidence for KERENDIA in people with T2D and CKD.
  • The rate of treatment-emergent adverse events (TEAEs) was 47.1% for those treated with finerenone and 49.2% for placebo.
  • The rate of treatment-emergent serious adverse events was 11.8% for finerenone and 11.5% for placebo.
  • Hyperkalemia, an adverse event of special interest, was observed more frequently with finerenone (10.1%) compared to placebo (3.3%). The rate of treatment discontinuation due to hyperkalemia was 1.7% and 0%, respectively. ¹

Detailed FINE-ONE trial results were presented at the American Society of Nephrology (ASN) Kidney Week 2025 and published in the New England Journal of Medicine.

About KERENDIA

KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys.⁶

About KERENDIA’s Clinical Trial Program

KERENDIA’s clinical trial program — called FINEOVATE — currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL).

• The MOONRAKER program includes FINEARTS-HF⁶ as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF,⁷ CONFIRMATION-HF⁸ and FINALITY-HF.⁹
• The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD,¹⁰ FIGARO-DKD,¹¹ FINE-ONE¹² and FIND-CKD¹³ as well as the ongoing investigational studies, FIONA¹⁴ and FIONA-OLE.¹⁵

INDICATIONS:

KERENDIA (finerenone) is indicated to reduce the risk of:

• sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
• cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• Hypersensitivity to any component of this product
• Concomitant use with strong CYP3A4 inhibitors
• Patients with adrenal insufficiency

WARNINGS AND PRECAUTIONS:

• Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia.
  
  Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.

• Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed.
  
  Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m² is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function.

MOST COMMON ADVERSE REACTIONS:

• CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
• HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%).¹⁶ Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

DRUG INTERACTIONS:

• Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
• Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.
• Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
• Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS:

• Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
• Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

Please see the Prescribing Information for KERENDIA.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

Bayer’s legacy in cardiovascular care spans decades of scientific innovation and patient-focused research. As a long-standing leader in cardiology, Bayer has consistently advanced therapies that address the complex interplay between the heart and kidneys—two organs deeply connected in both health and disease. Today, that heritage continues to guide our commitment to developing innovative treatments for patients facing high unmet medical needs. With a growing portfolio of approved therapies and promising compounds in development, Bayer is shaping the future of cardiovascular care through precision medicine, scientific rigor, and a deep sense of purpose.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

¹ Heerspink HJL, Birkenfeld AL, Cherney DZI, et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. New England Journal of Medicine. 2026;394(10):947-957. doi:https://doi.org/10.1056/nejmoa2512854
² Rossing P, Per-Henrik Groop, Singh R, Lawatscheck R, Tuttle KR. Prevalence of Chronic Kidney Disease in Type 1 Diabetes Among Adults in the U.S. Diabetes Care. Published online June 10, 2024. doi:https://doi.org/10.2337/dc24-0335
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. The Lancet Regional Health - Americas. 2025;47:101130. doi:https://doi.org/10.1016/j.lana.2025.101130
⁴ U.S. Food and Drug Administration. “Priority Review.” https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed April 7, 2026.
⁵ KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc: August 2025.
⁶ Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF) Clinical trial registration No. NCT04435626. https://clinicaltrials.gov/study/NCT04435626 Accessed March 4, 2026
⁷ A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). Clinical trial registration No. NCT 06008197. https://www.clinicaltrials.gov/study/NCT06008197. Accessed March 10, 2025.
⁸ A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION). Clinical trial registration No. NCT06024746. https://www.clinicaltrials.gov/study/NCT06024746. Accessed March 10, 2025.
⁹ A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF). Clinical trial registration No. NCT06033950. https://www.clinicaltrials.gov/study/NCT06033950. Accessed March 10, 2025.
¹⁰ Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Clinical trial registration No. NCT02540993. https://clinicaltrials.gov/study/NCT02540993. Accessed March 4, 2026.
¹¹ Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD) Clinical trial registration No. NCT02545049 https://clinicaltrials.gov/study/NCT02545049. Accessed March 4, 2026.
¹² 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). Clinical trial registration No. NCT05901831. https://www.clinicaltrials.gov/study/NCT05901831. Accessed March 10, 2025.
¹³ A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical trial registration No. NCT05047263. https://www.clinicaltrials.gov/study/NCT05047263. Accessed March 10, 2025.
¹⁴ A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria (FIONA). Clinical trial registration No. NCT05196035. https://www.clinicaltrials.gov/study/NCT05196035. Accessed March 10, 2025.
¹⁵ A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (FIONA OLE). Clinical trial registration No. NCT05457283. https://www.clinicaltrials.gov/study/NCT05457283. Accessed March 10, 2025.
¹⁶ Data on file.