ACC.25: Bayer Presents New Investigational Heart Failure Data and Continued Portfolio Research in Chronic Kidney Disease in Type 2 Diabetes

• Presentations at the American College of Cardiology (ACC) 74^th Annual Scientific Session & Expo 2025 include 10 new prespecified subgroup analyses from FINEARTS-HF, the pivotal Phase III cardiovascular (CV) outcomes trial investigating KERENDIA® (finerenone) in heart failure (HF) patients with a left ventricular ejection fraction (LVEF) of ≥40%
• Additional data include a pooled analysis of the FINE-HEART trial, a causal mediation analysis of the FIDELITY trial and real-world research on patients with worsening HF within a large healthcare delivery system from 2012-2021
• KERENDIA is currently approved to reduce the risk of CV death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)¹

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today that data from 13 new analyses from across the KERENDIA® (finerenone) comprehensive clinical trial program will be presented at the American College of Cardiology (ACC) 74^th Annual Scientific Session & Expo 2025, taking place in Chicago, IL, from March 29-31, 2025.

Ten presentations will feature new data from the pivotal Phase III FINEARTS-HF cardiovascular (CV) outcomes trial, which investigated KERENDIA 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).

Additional ACC.25 presentations include:

• An analysis of FINE-HEART, an integrated, pooled, exploratory, participant-level analysis across three pivotal Phase III clinical trials with finerenone—FINEARTS-HF, FIDELIO-DKD and FIGARO-DKD,
• A post-hoc analysis of FIDELITY, a pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD trials that evaluated the long-term effects of KERENDIA on CV outcomes in patients with chronic kidney disease (CKD) in type 2 diabetes (T2D), and
• Real-world research on patients with worsening HF within a large healthcare delivery system from 2012-2021.

Details on abstracts presented by Bayer at ACC.25 are below:

• Efficacy and safety of finerenone across the spectrum of kidney risk in heart failure with mildly reduced or preserved ejection fraction
  • Session: Innovations and Insights in Heart Failure With Preserved Ejection Fraction: Emerging Therapies, Biomarkers and Mechanistic Studies
  • Abstract 904-09; March 29, 10:06am CT / 11:06am ET

• Efficacy and safety of finerenone according to New York Heart Association functional class in heart failure with mildly reduced or preserved ejection fraction
  • Session: Innovations and Insights in Heart Failure With Preserved Ejection Fraction: Emerging Therapies, Biomarkers and Mechanistic Studies
  • Abstract 904-11; March 29, 10:18am CT / 11:18am ET

• Finerenone, bilirubin, and heart failure with mildly reduced or preserved ejection fraction: an analysis from FINEARTS-HF
  • Session: Innovations and Insights in Heart Failure With Preserved Ejection Fraction: Emerging Therapies, Biomarkers and Mechanistic Studies
  • Abstract 904-21; March 29, 11:18am CT / 12:18pm ET

• Efficacy of finerenone according to left atrial size in patients with heart failure and mildly reduced or preserved ejection fraction: An analysis of the FINEARTS-HF trial
  • Session: Finerenone: A Promising Addition to the Armamentarium or Merely an Academic Exercise?
  • Abstract 920-05; March 29, 12:12pm CT / 1:12pm ET

• Finerenone in patients with HFmrEF/HFpEF with and without atrial fibrillation: a prespecified analysis of FINEARTS-HF
  • Session: Finerenone: A Promising Addition to the Armamentarium or Merely an Academic Exercise?
  • Abstract 920-09; March 29, 12:36pm CT / 1:36pm ET

• Finerenone, chronic obstructive pulmonary disease, and heart failure with mildly reduced or preserved ejection fraction: An analysis of FINEARTS-HF
  • Session: Finerenone: A Promising Addition to the Armamentarium or Merely an Academic Exercise?
  • Abstract 920-15; March 29, 1:12pm CT / 2:12pm ET

• Efficacy and safety of finerenone in patients with heart failure and mildly reduced or preserved ejection fraction: A prespecified anemia-specific analysis of the FINEARTS-HF trial
  • Session: Finerenone: A Promising Addition to the Armamentarium or Merely an Academic Exercise?
  • Abstract 920-19; March 29, 1:36pm CT / 2:36pm ET

• Effect of finerenone on N-terminal pro-B-type natriuretic peptide in heart failure with mildly reduced or preserved ejection fraction: The FINEARTS-HF trial
  • Session: Finerenone: A Promising Addition to the Armamentarium or Merely an Academic Exercise?
  • Abstract 920-21; March 29, 1:48pm CT / 2:48pm ET

• Temporal changes in biomarkers and quality of life prior to adverse clinical outcomes in heart failure with mildly reduced or preserved ejection fraction
  • Session: Heart Failure and Cardiomyopathies 04
  • Abstract 1091-184; March 29, 2:00pm CT / 3:00pm ET

• Mode of death in patients with heart failure with mildly reduced or preserved ejection fraction: The FINEARTS-HF trial
  • Session: Heart Failure With Preserved Ejection Fraction: Utility of Hemodynamic Data, Treatment Options and Mode of Death
  • Abstract 949-05; March 30, 9:12am CT / 10:12am ET

• Finerenone reduces new-onset atrial fibrillation across the spectrum of cardio-kidney-metabolism: The FINE-HEART pooled analysis
  • Session: Heart Failure and Cardiomyopathies 09
  • Abstract 1194-184; March 30, 1:30pm CT / 2:30pm ET

• Worsening heart failure events in adults with mild-to-moderate chronic kidney disease
  • Session: Heart Failure and Cardiomyopathies 10
  • Abstract 1215-174; March 30, 3:00pm CT / 4:00pm ET

• Mechanisms of cardiovascular benefit with finerenone – a causal mediation analysis of the joint effects of systolic blood pressure and albuminuria reduction
  • Session: Optimizing Cardiovascular Risk Across the Diabetes/Cardio-Kidney-Metabolic Spectrum
  • Abstract 991-21; March 31, 10:48am CT / 11:48am ET

About KERENDIA® (finerenone)¹

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 heart failure (HF) in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

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.

Reference

1. 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 March 11, 2025.

Contacts

Media Contact:
Elaine Colón
Bayer Media Relations
Elaine.colon@bayer.com
+1 732-236-1587