FDA Accepts, Grants Priority Review Designation for Bayer's msNRA for Patients with Heart Failure

March 17, 2025 — Bayer recently announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental new drug application (sNDA) and granted Priority Review designation for KERENDIA (finerenone) for the treatment of adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e., mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).

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

Approximately 6.7 million adults in the U.S. live with HF,² a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood.⁷ Of these patients, about 55% have a LVEF ≥40%.² Most are balancing multiple comorbidities, such as obesity, diabetes, hypertension and chronic kidney disease (CKD).⁷

“People with heart failure with mildly reduced or preserved ejection fraction face substantial challenges in diagnosis, treatment and follow-up care,” said Robert Perkins, M.D., MPH, FACP, Vice President, US Medical Affairs, Bayer. “In fact, a 2024 report on heart failure trends and outcomes published in the Journal of Cardiac Failure showed that in patients with heart failure with preserved ejection fraction, 5-year mortality was 75.7%.⁸ The FDA’s decision to grant Priority Review designation to our application underlines the significant unmet need these patients face.”

“KERENDIA is already an established pillar of therapy to improve cardiovascular outcomes for patients with type 2 diabetes and chronic kidney disease, and Bayer is committed to investigating KERENDIA’s benefits in other patient populations, including heart failure,” said Alanna Morris-Simon, M.D., MSc, Senior Medical Director of U.S. Medical Affairs, Bayer. “If approved for patients with heart failure with a left ventricular ejection fraction of ≥40%, KERENDIA will be an important new treatment option with the potential to become a pillar of therapy to provide cardiovascular benefits in another patient population with unmet need.”

The regulatory submission was based on the positive results from the Phase III FINEARTS-HF trial, which showed finerenone achieved a statistically significant reduction of the composite of CV death and total (first and recurrent) HF events, defined as either a hospitalization for HF or an urgent HF visit, by 16% in patients with HF and a LVEF of ≥40% compared to placebo in addition to a patient’s prescribed treatment regimen. Serious adverse events were comparable between treatment groups, occurring in 38.7% (1,157/2,993) of the finerenone group and 40.5% (1,213/2,993) of the placebo group. Detailed results were presented at ESC Congress 2024 and simultaneously published in the New England Journal of Medicine.¹ FINEARTS-HF is part of KERENDIA’s MOONRAKER program. MOONRAKER is expected to be one of the largest HF study programs to date with more than 15,000 patients in total and aims to establish a comprehensive body of evidence for finerenone across a broad spectrum of patients and clinical settings.⁵

References

1. Solomon S, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa2407107. Accessed February 21, 2025.

2. Bozkurt A, et al. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023; Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. PMID: 37797885; PMCID: PMC10864030.

3. Desai N, et al. Heart failure with mildly reduced and preserved ejection fraction: A review of disease burden and remaining unmet medical needs within a new treatment landscape. Heart Fail Rev. 2024;29(3):631-662. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11035416/. Accessed November 20, 2024.

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 March 5, 2025.

5. Data on file.

6. Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf. Accessed February 21, 2025.

7. Heidenreich P, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2023. https://pubmed.ncbi.nlm.nih.gov/35379503. Accessed November 20, 2024.

8. Bozkurt A, et al. HF STATS 2024: Heart Failure Epidemiology and Outcomes Statistics: An Updated 2024 Report from the Heart Failure Society of America. J Card Fail. 2025 Jan;31(1):66-116. Doi: 10.1016/j.cardfail.2024.07.001. Epub 2024 Sep 24.

9. Trial to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) 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 February 21, 2025.

10. 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.

11. 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.

12. 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.

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. 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.

17. A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes (CONFIDENCE). Clinical trial registration No. NCT05254002. https://www.clinicaltrials.gov/study/NCT05254002. Accessed March 10, 2025.

18. American Diabetes Association (Section 10: Cardiovascular disease and risk management: standards of care in diabetes—2024.). Diabetes Care. 2024;47(Suppl. 1):S179-S218. doi:10.2337/dc24-S010.

19. Marx N, et al. ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J . 2023;44(39):4043-4140. doi:10.1093/eurheartj/ehad192.