Bayer to Share New Data from KERENDIA® (finerenone) Clinical Trial Program at European Renal Association Congress

• Presentations will highlight new investigational data on finerenone, including results from the CONFIDENCE trial assessing combination therapy with empagliflozin, and sub analyses from FINEARTS-HF on the effects of finerenone on eGFR slope, albuminuria, and cardiovascular outcomes

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that it will present multiple new analyses of the KERENDIA ^® (finerenone) clinical trial program at the European Renal Association (ERA) 62^nd Congress scientific sessions in Vienna, Austria, June 4-7, 2025.

KERENDIA is currently approved to reduce the risk of cardiovascular death, hospitalization for heart failure (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).¹

Data being presented at ERA include:

Effect of Finerenone on eGFR Slope Across Different Levels of Baseline Albuminuria: Insights from FINEARTS-HF

• Thursday, June 5, 2025, 2:51 am (ET) / 08:51 am (CEST)

THE COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with CKD and type 2 diabetes using a UACR Endpoint (CONFIDENCE) TRIAL: Efficacy/Safety of Combining Finerenone with Empagliflozin in People with Chronic Kidney Disease and Type 2 Diabetes

• Thursday, June 5, 2025, 5:40 am (ET) / 11:40 am (CEST)

Changes in Albuminuria and The Effect of Finerenone on Cardiovascular Outcomes: Insights from FINEARTS-HF

• On-demand content will be available for this poster session, available from Friday, June 6, 2025, 12:00 pm (ET) / 18:00 pm (CEST)

About KERENDIA^® (finerenone) ¹

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 heart failure in adults with CKD associated with 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.

^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 June 2, 2025.