Late-Breaking KERENDIA^® (finerenone) Investigational Data Showed a Statistically Significant Reduction in the Composite Outcome of Cardiovascular Death and Total Heart Failure Events in Adult Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction

• The primary endpoint results were consistent across all prespecified subgroups ¹
• KERENDIA is the first-and-only non-steroidal mineralocorticoid receptor antagonist (MRA) to meet a primary composite cardiovascular endpoint in a Phase III trial investigating patients with HF with mildly reduced or preserved ejection fraction (LVEF ≥40%)¹
• Results from FINEARTS-HF were simultaneously published in the New England Journal of Medicine

Detailed results from the Phase III FINEARTS-HF trial presented today at the European Society of Cardiology (ESC) Congress 2024 during a late-breaking Hot Line session and simultaneously published in the New England Journal of Medicine showed that KERENDIA^® (finerenone) achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) heart failure (HF) events, defined as either an unplanned hospitalization for HF or an urgent HF visit, by 16% (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007) in patients with HF and a LVEF ≥40% (left ventricular ejection fraction) compared to placebo in addition to a patients’ prescribed treatment regimen.¹

KERENDIA is the first-and-only non-steroidal mineralocorticoid receptor antagonist (MRA) to meet a primary composite cardiovascular endpoint in a Phase III trial investigating patients with HF and LVEF ≥40%.¹

KERENDIA is currently approved to reduce the risk of cardiovascular death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained eGFR decline, and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).²

KERENDIA already has established cardiovascular benefit (reduction in hospitalization for HF, CV death and non-fatal MI) in adults with CKD associated with T2D,² and this new data provides positive results in a different patient population not limited to CKD in T2D – patients diagnosed with HF (LVEF ≥40).¹

FINEARTS-HF is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, event-driven Phase III trial. It is investigating the efficacy and safety of finerenone for the reduction of risk of cardiovascular death and HF events in patients with a diagnosis of symptomatic HF (New York Heart Association class II-IV) with a LVEF of ≥40%, a measurement that indicates how much blood the left ventricle of the heart pumps with each beat.³ In the FINEARTS-HF trial, no new safety signals were identified compared with those seen in previous studies with the compound.¹

“Treating heart failure patients with LVEF ≥40% has provided a challenge for many physicians, as these patients have a substantial risk for cardiovascular events. Unlike heart failure with reduced ejection fraction, there are limited guideline-directed options for heart failure with LVEF >40%,” said Scott D. Solomon, MD, The Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School, Director of Non-invasive Cardiology and Senior Physician at Brigham and Women’s Hospital and Chair of the trial’s Executive Committee. “FINEARTS-HF is the first large-scale trial where a non-steroidal mineralocorticoid receptor antagonist met a primary composite cardiovascular endpoint in patients with heart failure with mildly reduced or preserved ejection fraction (LVEF >40%), and these results provide insights for the cardiology community managing these high-risk patients.”

“Bayer has a strong heritage in cardiology, and heart failure is a key focus area for us, with these results underpinning our ongoing commitment to patients with this devastating condition. Based on FINEARTS-HF, KERENDIA has shown to reduce the risk of cardiovascular outcomes in a complex to treat patient population,” said Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division.

The results shown in the primary endpoint results were consistent across all prespecified subgroups. Secondary outcomes tested hierarchically included total number of worsening HF events (rate ratio, 0.82; 95% confidence interval [CI], 0.71 to 0.94, p=0.006) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS) assessed at months six, nine and 12. There was a mean change from baseline in the KCCQ-TSS of 8 points in the finerenone group and 6.4 points in the placebo group (between-group difference of 1.6 points; 95%CI, 0.8 to 2.3, p<0.001).

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. 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. While hyperkalemia was more common with finerenone, it rarely led to hospitalization (0.5% [16/2,993] versus 0.2% [6/2,993] in the placebo group), and no cases resulted in death.¹

HF is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood.⁴ Approximately 6.7 million adults in the U.S. live with HF, of whom about 55% have a LVEF ≥40%.5 Despite the high prevalence, guideline-directed medical treatment options for patients with HF with LVEF ≥40% are limited.⁶ This patient group is often balancing multiple comorbidities, such as obesity, hypertension and CKD.⁴

Bayer plans to discuss this data and submission for regulatory approval with the U.S. Food and Drug Administration (FDA).

About FINEARTS-HF³

FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III trial investigating the efficacy and safety of KERENDIA^® (finerenone) for the reduction of risk of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (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, who received diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.

Approximately 6,000 patients were randomized to receive KERENDIA or placebo once daily for up to 42 months. Results showed that KERENDIA once daily in addition to a patients’ prescribed treatment regimen reduced the composite of total worsening HF events and cardiovascular death in patients with HF and mildly reduced or preserved ejection fraction. KERENDIA also significantly reduced the secondary endpoints of total HF events (HR 0.82 [95% CI, 0.71-0.94; p=0.0062]) and improved patient-reported health status as measured by the change from baseline in Total Symptom Score of Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) (between-group difference 1.6 points [95% CI, 0.8-2.3; p<0.0001]).

With overall more than 15,000 patients, the MOONRAKER clinical trial program with KERENDIA, including FINEARTS-HF, is one of the largest HF trial programs to date and aims to establish a comprehensive body of evidence for KERENDIA across a broad spectrum of patients and clinical settings.¹

About KERENDIA^® (finerenone)²

KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) and was approved by the U.S. Food and Drug Administration (FDA) in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for HF in adults with CKD associated with T2D.

In adults with CKD associated with T2D, KERENDIA has been recommended to reduce the risk of hospitalization for HF by the American Diabetes Association (ADA)⁷ and European Society of Cardiology (ESC).⁸

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’s Commitment in Cardiovascular and Kidney Diseases

A leader in the cardiovascular (CV) space, Bayer upholds a long-standing commitment to delivering science for a better life by advancing research and treatment options. Bayer’s cardiorenal franchise, which began with the discovery and development of a number of vital therapies, now includes several products and compounds in various stages of preclinical and clinical development with the potential to impact the way that CV and kidney diseases are treated.

Bayer is investigating potential treatment approaches for areas of high unmet medical need. Currently, Bayer is investigating nine CVR-related projects in different stages of development, including heart failure (HF) and non-diabetic chronic kidney disease (CKD).⁹

Bayer is actively identifying resources and programs aimed at better understanding the real-world management of CKD, expanding screening and early care management for CKD, aligning with and supporting groups and institutions that share the common goals of improving health outcomes, promoting health literacy and education, and promoting research and initiatives that represent the diversity required to address the needs of all patients.

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.

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¹ Data on file.

² 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 August 30, 2024.

³ Study 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 August 30, 2024.

⁴ 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 August 30, 2024.

⁵ 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.

⁶ 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 August 30, 2024.

⁷ 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.

⁸ 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.

⁹ Bayer Pharmaceuticals. Development Pipeline. U.S. https://www.bayer.com/en/pharma/development-pipeline. Accessed August 30, 2024.

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