Bayer receives positive CHMP opinion for finerenone as a new treatment for patients with chronic kidney disease and type 2 diabetes

Bayer receives positive CHMP opinion for finerenone as a new treatment for patients with chronic kidney disease and type 2 diabetes

• Finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist,¹ is recommended by the CHMP for marketing authorisation in the EU for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D)²
• CHMP opinion is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of finerenone on kidney and cardiovascular outcomes in patients with CKD associated with T2D^1,3
• Final European Commission decision is expected in the coming months

 

Reading, 17^th December 2021 – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist,¹ for marketing authorisation in the European Union (EU). Finerenone (10 mg or 20 mg) is recommended for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.²

 

“Despite currently available treatment options, many patients with chronic kidney disease associated with type 2 diabetes progress to kidney failure or premature death.^4,5,6 These patients have a critical need for treatment options that can delay kidney disease progression and reduce the risk of cardiovascular events,”^4,5,6 said Professor Peter Rossing, Head of Complications Research at the Steno Diabetes Center Copenhagen. “Once approved, finerenone will be the first non-steroidal MR antagonist to offer adult patients living with chronic kidney disease associated with type 2 diabetes a new form of therapy to help improve kidney outcomes.”¹

 

“Chronic kidney disease often progresses silently and unpredictably, with many symptoms not apparent until the disease is advanced.^7,8 Timely detection is vital to ensure the best outcomes for patients and kidney health needs to be carefully monitored in those at-risk,⁹” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “The positive CHMP opinion for finerenone brings us closer to providing this new treatment option to patients with chronic kidney disease associated with type 2 diabetes.”

 

The positive CHMP opinion is based on the results of the pivotal Phase III FIDELIO-DKD study,¹ presented at the American Society of Nephrology’s (ASN) Kidney Week 2020 and simultaneously published in the New England Journal of Medicine (NEJM) in October 2020.

 

In July 2021, finerenone was approved under the brand name Kerendia^® by the United States (U.S.) Food and Drug Administration (FDA) based on the positive results of the FIDELIO-DKD Phase III study for adult patients with CKD and T2D.¹ Finerenone has also been submitted for marketing authorisation in China and multiple other countries worldwide; these applications are currently under review.

 

About Finerenone
Finerenone (BAY 94-8862) is an investigational novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block many of the harmful effects of mineralocorticoid receptor (MR) overactivation in preclinical models.^10-14  MR overactivation is believed to be a major driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.^15-17 The Phase III study programme, FINEOVATE, currently comprises five Phase III studies, FIDELIO-DKD¹⁸, FIGARO-DKD¹⁹, FIND-CKD²⁰, FINEARTS-HF²¹ and FIONA²².

 

Having randomised more than 13,000 patients with CKD and T2D around the world, the Phase III programme in CKD and T2D comprises two completed and published studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.²³ FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D.¹⁸ 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 standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D.¹⁹  

 

FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), a prespecified meta-analysis of more than 13,000 patients from the Phase III FIDELIO-DKD and FIGARO-DKD studies, evaluated the occurrence of progression of kidney disease as well as fatal and nonfatal CV events in patients with CKD and T2D.²⁴ The meta-analysis investigated the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes risk categories)⁹ and the effects of finerenone on composite cardiovascular and kidney-specific endpoints.²⁴

 

In November 2021, Bayer announced the initiation of FIONA, a multicentre, randomised, double-blind, placebo-controlled Phase III study, to investigate the efficacy, safety and pharmacokinetics/pharmacodynamics (PK/PD) of finerenone, in addition to standard of care, in approximately 200 paediatric patients with chronic kidney disease (CKD) and severely increased proteinuria.²²

 

In September 2021, Bayer announced the initiation of the Phase III study FIND-CKD, a multicentre, randomised, double-blind, placebo-controlled Phase III study to investigate the efficacy and safety of finerenone in addition to guideline-directed therapy on the progression of chronic kidney disease (CKD) in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys).²⁰

 

In June 2020, Bayer announced the initiation of the FINEARTS-HF study, a multicentre, randomised, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 patients with symptomatic heart failure (New York Heart Association class II-IV) with preserved ejection fraction, i.e. a left ventricular ejection fraction of ≥40%.²¹ 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 (HF) events (defined as hospitalizations for HF or urgent HF visits).²¹

 

About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a common and potentially deadly condition that is generally underrecognised.²⁵ CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.^26,27 Up to 40% of all patients with type 2 diabetes develop chronic kidney disease.^4,28,29 Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events.^4,5,6 It is estimated that CKD affects more than 160 million people with T2D worldwide.^26,30,31 Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease,⁴ which requires dialysis or a kidney transplant to stay alive.³² Patients with chronic kidney disease and type 2 diabetes are around three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.³³

 

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

Bayer is an innovation leader in the area of cardiovascular 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 cardiovascular 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 prioritises targets and pathways with the potential to impact the way that cardiovascular 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 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.co.uk.

 

Contacts for media enquiries:

Dr. Daniela Esser, phone +49 30 468-15805

Email: daniela.esser@bayer.com

 

Veronica Yao, phone +44 (0) 7870 485 926

Email: veronica.yao.ext@bayer.com

 

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.co.uk. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

 

 

References:

1.     Bakris G et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. New England      Journal of Medicine. 2020. 383, 2219-2229.

2.     Kerendia (finerenone) was granted a positive opinion for treatment of chronic kidney disease associated with type 2 diabetes in adults. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021. Last accessed December 2021.

3.     Filippatos G, et al. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021;143:540–552

4.     Alicic R Z et al. Diabetic Kidney Disease: Challenges, Progress, and Possibilities. Clinical Journal of the American Society of Nephrology. 2017. 12(12), 2032–2045.

5.     Anders, H J, et al. CKD in diabetes: diabetic kidney disease versus nondiabetic kidney disease. Nature Reviews Nephrology. 2018. 14, 361–377.

6.     Thomas M C, et al. Diabetic kidney disease. Nature Reviews Disease Primers. 2015; 1:15018.

7.     Zhong J, et al. A perspective on chronic kidney disease progression. American Journal of Physiology-Renal Physiology. 2017. 312(3), F375-F384.

8.     Khan Y H, et al. Prevalence of Chronic Kidney Disease in Asia: A Systematic Review of Population-based Studies. Journal of the College of Physicians and Surgeons Pakistan. 2018. 28(12), 960-6.

9.     KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney International. 2013. 3, 1-150.

10.   Kolkhof P et al. Finerenone, a novel selective nonsteroidal mineralocorticoid receptor antagonist protects from rat cardiorenal injury. Journal of Cardiovascular Pharmacology and Therapeutics. 2014. 64, 69-78.

11.   Kolkhof P et al. Nonsteroidal antagonists of the mineralocorticoid receptor. Current Opinion in Nephrology and Hypertension. 2015. 24, 417-424.

12.   Grune J, Beyhoff N, Smeir E et al. Selective mineralocorticoid receptor cofactor modulation as molecular basis for finerenone's antifibrotic activity. Hypertension 2018; 71:599–608.

13.   Lattenist L, Lechner SM, Messaoudi S et al. Nonsteroidal mineralocorticoid receptor antagonist finerenone protects against acute kidney injury-mediated chronic kidney disease: role of oxidative stress. Hypertension 2017; 69:870–878.

14.   Barrera-Chimal J, Estrela GR, Lechner SM et al. The myeloid mineralocorticoid receptor controls inflammatory and fibrotic responses after renal injury via macrophage interleukin-4 receptor signaling. Kidney Int 2018; 93:1344–1355.

15.   Bauersachs J, et al. Mineralocorticoid receptor activation and mineralocorticoid receptor antagonist treatment in cardiac and renal diseases. Journal of Hypertension. 2015. 65, 257-263.  

16.   Barrera-Chimal J, Girerd S, Jaisser F. Mineralocorticoid receptor antagonists and kidney diseases: pathophysiological basis. Kidney Int 2019; 96:302–319.

17.   Buonafine M, Bonnard B, Jaisser F. Mineralocorticoid receptor and cardiovascular disease. Am J Hypertens 2018; 31:1165–1174.

18.   ClinicalTrials.gov. Efficacy and Safety of Finerenone in Subjects with Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD). 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT02540993. Last accessed: December 2021.

19.   ClinicalTrials.gov. Efficacy and Safety of Finerenone in Subjects with Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD). 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT02545049. Last accessed: December 2021.

20.   ClinicalTrials.gov. A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Available at: https://clinicaltrials.gov/ct2/show/NCT05047263?term=FIND-CKD&draw=2&rank=1. Last accessed: December 2021

21.   ClinicalTrials.gov. 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). 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04435626. Last accessed: December 2021.

22.   Bayer global press release on 15^th November 2021. Bayer extends clinical development program for finerenone with Phase III study in children and adolescents with chronic kidney disease.

23.   Ruilope L M et al. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial. American Journal of Nephrology. 2019. 50(5), 345-356.

24.   Agarwal, R. and Filippatos, G et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. European Heart Journal (2001) 00, 1-12. Available at: https://doi.org/10.1093/eurheartj/ehab777.

25.   Breyer MD et al. Developing Treatments for Chronic Kidney Disease in the 21st Century. Seminars in Nephrology. 2016. 36(6), 436–447.

26.   International Diabetes Federation. IDF Diabetes Atlas Ninth Edition. 2019.

27.   Weiner DE et al. Chronic kidney disease as a risk factor for cardiovascular disease and all-cause mortality: a pooled analysis of community-based studies. J Am Soc Nephrol 2004; 15:1307-1315.

28.   Doshi SM et al. Diagnosis and management of type 2 diabetic kidney disease. Clinical Journal of the American Society of Nephrology, 12(8), 1366-1373. 2017.

29.   International Diabetes Federation. Diabetes and Kidneys. Available at: https://idf.org/our-activities/care-prevention/diabetes-and-the-kidney.html. Last Accessed: December 2021.

30.   Zheng Y et al. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nature Reviews Endocrinology. 2018. 14(2), 88-98.

31.   Wu B et al. Understanding CKD among patients with T2DM: prevalence, temporal trends, and treatment patterns—NHANES 2007–2012. British Medical Journal Open Diabetes Research and Care. 2016. 4(1), e000154.

32.   Kidney Fund.org. Kidney Failure. Available at: https://www.kidneyfund.org/kidney-disease/kidney-failure/ Last accessed: December 2021.

33.   Afkarian M, et al. Kidney Disease and Increased Mortality Risk in Type 2 Diabetes. Journal of the American Society of Nephrology. 2013. 24(2), 302-8.

 

PP-KER-GB-0017 / December 2021