Bayer to Highlight New Data for KERENDIA® (finerenone) at Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025

September 25, 2025 at 08:00 AM EDT

Data to be presented include two subgroup analyses from the pivotal Phase III FINEARTS-HF trial, which assessed the safety and efficacy of finerenone versus placebo in heart failure (HF) patients with left ventricular ejection fraction (LVEF) ≥40%. These analyses explored potential treatment effects in patients across a range of heart failure duration or who have high medication burden.
Additionally, retrospective real-world data will be presented on guideline-directed medical therapy treatment patterns in the U.S. for newly diagnosed HF, stratified by LVEF, as well as on clinical outcomes after onset of HF with LVEF ≥40%.

Bayer announced today that data from across the KERENDIA^® (finerenone) comprehensive clinical trial program will be presented at the Heart Failure Society of America (HFSA)’s Annual Scientific Meeting in Minneapolis, Minnesota, September 26-29, 2025.

In July 2025, the U.S. Food and Drug Administration (FDA) approved a new indication for KERENDIA to treat adult patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA).¹ Since July 2021, KERENDIA has been 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 CKD associated with T2D.¹

Data from Bayer at HFSA include:

Finerenone, Polypharmacy, And Clinical Outcomes In Heart Failure: Insight From The FINEARTS-HF Trial
- Board and Poster: 134; September 27, 7:45 – 8:15 AM CDT
Clinical Outcomes After Onset Of Heart Failure With Left Ventricular Ejection Fraction ≥40%
- Board and Poster: 174; September 27, 8:15 – 8:45 AM CDT
Guideline Directed Medical Therapy Treatment Patterns In Heart Failure Stratified By Ejection Fraction
- Board and Poster: 198; September 27, 12:45 – 1:15 PM CDT
Effects of Finerenone Across A Range of Heart Failure Duration: A Prespecified Analysis Of The FINEARTS-HF Trial
- Board and Poster: 068; September 28, 12:51 – 1:01 PM CDT

About KERENDIA^® (finerenone)¹

INDICATION:

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%). 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 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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros.

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 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215341s009lbl.pdf. Accessed September 24, 2025.

COR-KER-US-0162-1

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Media Contact:

Elaine Colón

Bayer Media Relations

elaine.colon@bayer.com

+1-732-236-1587

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Bayer to Highlight New Data for KERENDIA® (finerenone) at Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025

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