U.S. FDA Accepts Supplemental New Drug Application Under Priority Review for New Indication for KERENDIA® (finerenone) in Patients with Heart Failure with Left Ventricular[...]

March 17, 2025

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

About FINEARTS-HF ⁹
The FINEARTS-HF trial, a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III trial investigated the efficacy and safety of finerenone for the reduction of risk of cardiovascular (CV) death and heart failure (HF) events in patients with a diagnosis of symptomatic HF (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by local imaging measurement within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of CV and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. Approximately 6,000 patients were randomized to receive finerenone or placebo once daily for up to 42 months.

Results from FINEARTS-HF, which were published in The New England Journal of Medicine , showed the trial met its primary endpoint, achieving a 16% (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007) relative risk reduction of the composite primary endpoint of CV death and total (first and recurrent) HF events (defined as hospitalizations for HF or urgent HF visits) compared to placebo in addition to a patients' prescribed treatment regimen.¹

In the FINEARTS-HF trial, no new safety signals were identified compared with those seen in previous studies with the compound.¹ 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. Discontinuation of the trial drug for reasons other than death was similar between groups, with 20.4% (611/2,993) in the finerenone group and 20.6% (616/2,993) in the placebo group.¹

Increases in creatinine and potassium levels were more frequent in patients receiving finerenone compared to placebo, with investigator-reported hyperkalemia in 9.7% (289/2,993) of finerenone-treated patients versus 4.2% (125/2,993) in the placebo group. Serum potassium levels >6 mmol/L were observed in 3% (n=86) of the finerenone group compared to 1.4% (41/2,993) in the placebo group. Hyperkalemia was more common with finerenone; it led to hospitalization in 0.5% [16/2,993] in the finerenone group versus 0.2% [6/2,993] in the placebo group, and no cases resulted in death.¹

About Finerenone's Clinical Trial Program
Finerenone's clinical trial program-called FINEOVATE-currently comprises 10 Phase III studies with dedicated programs in heart failure (HF) (MOONRAKER) and chronic kidney disease (CKD) (THUNDERBALL) respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF¹⁰ , CONFIRMATION-HF¹¹ , and FINALITY-HF¹² . The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD¹³ , FIONA¹⁴ , FIONA-OLE¹⁵ , FINE-ONE¹⁶ , and the Phase II study CONFIDENCE.¹⁷

About KERENDIA^® (finerenone) ⁶
KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) and was approved by the U.S. Food and Drug Administration (FDA) in July 2021 to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular (CV) death, non-fatal myocardial infarction (MI), and hospitalization for HF in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

In adults with CKD associated with T2D, KERENDIA has been recommended to improve CV outcomes and reduce the risk of CKD progression by the American Diabetes Association (ADA)¹⁸ and reduce CV and kidney failure risk on top of standard of care by the European Society of Cardiology (ESC).¹⁹

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• 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 >5.0 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.

MOST COMMON ADVERSE REACTIONS:

• From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% versus 6.9%), hypotension (4.6% versus 3.9%), and hyponatremia (1.3% versus 0.7%).

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.

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 click here for full Prescribing Information for KERENDIA.

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 2023, the Group employed approximately 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items 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.

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.

Source: Bayer