Bayer to present new analyses adding to the depth of knowledge on the cardiovascular and renal outcomes of KERENDIA® (finerenone)

• New subgroup analysis from the FIGARO-DKD study will be presented at the American Society of Nephrology (ASN)’s Kidney Week 2021, which investigated the impact of finerenone, the first nonsteroidal mineralocorticoid receptor (MR) antagonist, on renal outcomes in patients with chronic kidney disease associated with type 2 diabetes
• Further analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, will be presented, which investigated the role of finerenone on renal outcomes by baseline therapy
• Additional finerenone data from the Phase III FIDELIO-DKD study and FIDELITY prespecified pooled analysis will be presented as late-breaking posters

Bayer will present new cardiovascular (CV) and renal subgroup analyses for KERENDIA^® (finerenone) from the comprehensive clinical trial program, including the FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from November 4-7, 2021. These data will be presented in scientific sessions in two oral presentations and two late-breaking posters, continuing to add to the growing body of data for patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

New Subgroup Analysis of Finerenone FIDELIO-DKD Data

The results of Bayer’s Phase III study FIDELIO-DKD were shared in October 2020 and simultaneously published in the New England Journal of Medicine. FIDELIO-DKD was the first trial in the finerenone Phase III clinical trial program, which evaluated finerenone in addition to standard of care (SoC) in patients with CKD associated with T2D for kidney-specific outcomes. The FIDELIO-DKD study met its primary and key secondary endpoint, which led to the July 9, 2021 FDA approval of KERENDIA 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 CKD associated with T2D.¹ At the upcoming ASN Kidney Week 2021, Bayer will present new subgroup analysis from FIDELIO-DKD, which explored how changes in urine albumin-to-creatinine ratio (uACR) can impact cardiovascular and renal outcomes in patients with CKD associated with T2D.

• Association of Urine Albumin-to-Creatinine Ratio and Its Early Change with Cardiorenal Outcomes in FIDELIO-DKD: A Mediation Analysis
  • November 4, 2021, 10 a.m. (PDT) / 6 p.m. (CEST)
  • Session: Late-Breaking Clinical Trials Posters
  • Poster: PO2531

Finerenone FIDELITY Prespecified Pooled Analysis Data

At the upcoming ASN Kidney Week 2021, Bayer will also present new findings from FIDELITY, the prespecified pooled analysis of both FIDELIO-DKD and FIGARO-DKD, which combines the trial populations of patients with CKD (stages 1-4) associated with T2D. This new analysis investigated the role of finerenone on renal outcomes by baseline therapy.

• Finerenone and Kidney Outcomes in Patients With CKD and T2D: Results From FIDELITY
  • November 4, 2021, 10 a.m. (PDT) / 6 p.m. (CEST)
  • Session: Late-Breaking Clinical Trials Posters
  • Poster: PO2531

• Finerenone in Patients with CKD and Type 2 Diabetes by SGLT-2i Treatment: The FIDELITY Analysis (Abstract SA-OR22)
  • November 6, 2021, 4:30-6:00 p.m. (PDT) / November 7, 12:30-2:00 a.m. (CEST)
  • Session: OR0602. Diabetic Kidney Disease: Recent Advances

Finerenone FIGARO-DKD Study Data

The results of Bayer’s Phase III study FIGARO-DKD were shared in August 2021 and simultaneously published in the New England Journal of Medicine. At the upcoming ASN Kidney Week 2021, Bayer will present additional subgroup analysis from FIGARO-DKD examining the impact of finerenone on renal outcomes.

• Finerenone and Kidney Outcomes in Patients with CKD and Type 2 Diabetes: Results From FIGARO-DKD (Abstract SA-OR21)
  • November 6, 2021, 4:30-6:00 p.m. (PDT) / November 7, 12:30-2:00 a.m. (CEST)
  • Session: OR0602. Diabetic Kidney Disease: Recent Advances

The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.² For more information, see “Important Safety Information” below.

About Finerenone Phase III Clinical Trials Program

Having randomized more than 13,000 patients with CKD associated with T2D around the world, the Phase III program with finerenone in CKD associated with T2D comprises two studies, evaluating the effect of finerenone versus placebo on top of standard of care (SoC) on both renal and CV outcomes.³

The FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) study was a randomized, double-blind, placebo-controlled, multicenter study in adult patients with CKD associated with T2D, defined as either having an uACR of 30 to 300 mg/g, eGFR 25 to 60 mL/min/1.73 m² and diabetic retinopathy, or as having an uACR of ≥300 mg/g and an eGFR of 25 to 75 mL/min/1.73 m².^1,2 The trial excluded patients with known significant nondiabetic kidney disease and a clinical diagnosis of chronic heart failure with reduced ejection fraction and persistent symptoms (NYHA class II to IV).² All patients were to have a serum potassium ≤4.8 mEq/L at screening and be receiving SoC background therapy, including a maximum tolerated labeled dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).² A total of 5,674 patients were randomized to receive finerenone (N=2,833) or placebo (N=2,841) and were followed for a median of 2.6 years.² The mean age of the study population was 66 years, and 70% of patients were male.² The trial population was 63% white, 25% Asian, and 5% Black.²

FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone versus placebo in addition to SoC on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD associated with T2D across 48 countries including sites in Europe, Japan, China and the U.S.^3,4 Finerenone 10 mg or 20 mg, orally once daily, was added to SoC, including blood glucose-lowering therapies and a maximum tolerated labeled dose of an ACEi or an ARB.^3,4 The FIGARO-DKD study was a randomized, double-blind, placebo-controlled, multicenter study in adult patients with CKD associated with T2D, defined as either having a UACR of ≥ 30 mg/g to <300 mg/g and an eGFR of 25 to 90 mL/min/1.73m2, or a UACR ≥ 300 mg/g and an eGFR ≥ 60 mL/min/1.73m2 at screening.⁴ Patients were required to have a serum potassium of ≤ 4.8 mmol/L at screening and received standard of care background therapy, including a maximum tolerated labeled dose of an ACEi or ARB.⁴

Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study that will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients (NYHA class II-IV) with a left ventricular ejection fraction of ≥40%.⁵ The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure events (defined as hospitalizations for heart failure or urgent heart failure visits).⁵

About KERENDIA (finerenone)

INDICATION:

• KERENDIA is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)²

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• Concomitant use with strong CYP3A4 inhibitors²
• Patients with adrenal insufficiency²

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/L²
  
  
  
  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 potassium²

MOST COMMON ADVERSE REACTIONS:

• Adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo: hyperkalemia (18.3% vs. 9%), hypotension (4.8% vs. 3.4%), and hyponatremia (1.4% vs. 0.7%)²

DRUG INTERACTIONS:

• Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice²
• 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 appropriate²
• Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers²

USE IN SPECIFIC POPULATIONS:

• Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment²
• 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) ²

Please read the Prescribing Information for KERENDIA.

About Chronic Kidney Disease Associated With Type 2 Diabetes

Patients with CKD associated with T2D are three times more likely to die from a CV-related cause than those with T2D alone.⁶ CKD is a serious and progressive condition that is generally underrecognized.⁷ CKD is a frequent complication arising from T2D and is also an independent risk factor of CV disease.^8-10 Approximately 40% of all patients with T2D develop CKD.⁸ Despite guideline-directed therapies, patients with CKD associated with T2D remain at high risk of CKD progression and CV events.^9-12 T2D is the leading cause of end-stage kidney disease, which requires dialysis or a kidney transplant to stay alive.^13-15

About Bayer’s Commitment in CV and Kidney Diseases

Bayer is an innovation leader in the area of CV diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for CV and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that CV diseases are treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its 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 drive sustainable development and generate 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 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 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. Bakris GL, Agarwal R, Anker SD, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025845

2. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2021.

3. Ruilope LM, Agarwal R, Anker SD, et al. Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial. Am J Nephrol. 2019;50(5):345-356. doi:10.1159/000503712

4. Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease (FIGARO-DKD). ClinicalTrials.gov. Accessed August 12, 2021. https://clinicaltrials.gov/ct2/show/NCT02545049

5. Study to evaluate the efficacy (effect on disease) and safety of finerenone on morbidity & mortality in participants with heart failure and left ventricular ejection fraction greater or equal to 40% (FINEARTS-HF). ClinicalTrials.gov. Accessed August 12, 2021. https://clinicaltrials.gov/ct2/show/NCT04435626

6. Afkarian M, Sachs MC, Kestenbaum B, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24(2):302-308. doi:10.1681/ASN.2012070718

7. Breyer MD, Susztak K. Developing treatments for chronic kidney disease in the 21st century. Semin Nephrol. 2016;36(6):436-447. doi:10.1016/j.semnephrol.2016.08.001

8. Bailey R, Wang Y, Zhu V, Rupnow MFT. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Res Notes. 2014;7(1):415. doi:10.1186/1756-0500-7-415

9. Anders HJ, Huber TB, Isermann B, Schiffer M. CKD in diabetes: diabetic kidney disease versus nondiabetic kidney disease. Nat Rev Nephrol. 2018;14(6):361-377. doi:10.1038/s41581-018-0001-y

10. Thomas MC, Brownlee M, Susztak K, et al. Diabetic kidney disease. Nat Rev Dis Primers. 2015;1:15018. doi:10.1038/nrdp.2015.18

11. American Diabetes Association standards of medical care in diabetes – 2021. Diabetes Care. 2021;44(1):1-244. https://care.diabetesjournals.org/content/diacare/suppl/2020/12/09/44.Supplement_1.DC1/DC_44_S1_final_copyright_stamped.pdf

12. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2013;3:5-14. https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf

13. National diabetes statistics report 2020: estimates of diabetes and its burden in the United States. Centers for Disease Control and Prevention. Accessed July 9, 2021. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

14. Stages of CKD. American Kidney Fund. Accessed May 11, 2021. https://www.kidneyfund.org/kidney-disease/chronic-kidney-disease-ckd/stages-of-chronic-kidney-disease/

15. Incidence, prevalence, patient characteristics, and treatment modalities. United States Renal Data System. Accessed July 9, 2021. https://adr.usrds.org/2020/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities

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