NICE publishes guidance recommending Bayer’s Kerendia®▼(finerenone) as an option for treating adult patients with chronic kidney disease associated with type 2 diabetes 

For UK Medical and Trade Media

 

  • Kerendia® (finerenone) is now available through NHS England as an option for treating chronic kidney disease (CKD) (stage 3 and 4 with albuminuria) associated with type 2 diabetes (T2D) in adults1 
  • Finerenone is the only licenced oral non-steroidal mineralocorticoid receptor antagonist for the treatment of CKD associated with T2D that has been recommended by NICE2
  • NICE recommendation is based on evidence from the pivotal Phase III FIDELIO-DKD study demonstrating the efficacy and safety profile of finerenone on kidney outcomes in patients with CKD associated with T2D3,4
  • Appraisal Committee highlights the unmet need for additional treatment options for CKD associated with T2D in the Guidance1

 

Today, the National Institute for Health and Care Excellence (NICE) has published a new guidance (TA877) recommending the use of finerenone (10mg and 20mg) by NHS England as an option for treating chronic kidney disease (CKD) (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.1 Finerenone is recommended as an add-on to optimised standard care, which should include, unless they are unsuitable, the highest tolerated licensed doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and sodium–glucose cotransporter-2 (SGLT2) inhibitors, for people who have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 or more.1

 

Publication of the NICE guidance on finerenone is based on the results of the pivotal Phase III FIDELIO-DKD study investigating the efficacy and safety profile of finerenone on kidney (primary composite endpoint) and cardiovascular (secondary composite endpoint) outcomes in 5,734 adult patients with CKD associated with T2D.3 The study showed that finerenone significantly reduced the risk of the primary composite renal outcome of time to kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥ 40% from baseline over a period of at least four weeks, or death from renal causes by 18% (relative risk reduction, absolute risk reduction 3.3%, HR 0.82 [95% CI, 0.73-0.93; p=0.001]) over a median duration of follow-up of 2.6 years compared to placebo (17.8% in finerenone group vs. 21.1% in placebo group experienced a primary composite renal outcome) when added to maximum tolerated dose of an ACE inhibitor or ARB.3 Based on an absolute between-group difference of 3.4% [95% CI, 0.6–6.2] at 36 months, the number needed to treat to prevent a primary composite renal event was 29 [95% CI, 16–166].3 In FIDELIO-DKD, there was a 14% relative risk reduction (absolute risk reduction, 1.8%; HR 0.86 [95% CI, 0.75-0.99; p=0.03]) in the key secondary cardiovascular endpoint, a composite of time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure, in those receiving finerenone compared to placebo (13% vs. 14.8%, respectively, experienced a key secondary cardiovascular event) over a median duration of 2.6 years follow-up.3 Finerenone was generally tolerated in the study.3 Hyperkalaemia events were the most frequently reported adverse reaction that occurred in 18.3% (516) of finerenone-treated patients (n= 2,827), compared with 9.0% (255) of placebo-treated patients (n=2,831). In patients treated with finerenone, most hyperkalaemia events were mild to moderate and resolved.3

 

Dr Kieran McCafferty, Consultant Nephrologist Barts Health NHS Trust, said: “People with chronic kidney disease associated with type 2 diabetes have significant risk of progression to kidney failure or premature death, particularly due to increased risk of cardiovascular disease compared with people with CKD alone. There has long been an unmet need for additional treatment options for people with CKD associated with T2D, especially as the residual risk of kidney disease progression and cardiovascular events remains high despite current therapies.1 The NICE recommendation of finerenone is therefore very welcome news and provides physicians with an important add-on option for protecting our patients by delaying kidney disease progression.” 

 

Dr Raj Thakkar, GP, Present Elect and CKD Lead, Primary Care Cardiovascular Society (PCCS), said: “Chronic kidney disease is one of the most common and burdensome complications of high-risk conditions including diabetes and hypertension.5 Without early identification and optimisation of treatment, CKD progresses over time leading to accelerated adverse renal and cardiovascular outcomes including end-stage kidney disease and coronary disease, heart failure, valve disease, stroke, and peripheral vascular disease. Building on the NICE guidance, the PCCS is developing a quality improvement programme to support colleagues to systematically and proactively identify and manage CKD in the primary care setting.”  

 

Alison Railton, head of policy and external affairs, Kidney Research UK, said: “Chronic kidney disease associated with type 2 diabetes is now the leading cause of kidney failure in the UK.6 It has a debilitating impact on patients’ lives yet is still not recognised as a major health condition. Today’s recommendation from NICE provides an additional treatment option and is good news for thousands of patients living with this long-term condition across the nation.”

 

In the UK, it is estimated that over 4.4 million people are living with type 2 diabetes, including almost one million undiagnosed,7 and as many as 40% of people with type 2 diabetes – approximately 1.76 million people, could eventually develop CKD in T2D.8 

 

A recent survey of patients with CKD associated with T2D (in the UK, France, Italy, Germany, and Spain), developed by the European Kidney Patients Federation in collaboration with Bayer AG, which included 100 UK patients, highlights that a CKD diagnosis not only has a profound physical impact on patients, but can also affect all aspects of a patient’s life including career, finances, and mental health.9 Results show that respondents in the UK were the most likely to have experienced depression (67% vs. 57% overall) with CKD in T2D.9 Findings of the survey, published on this year’s ahead of World Kidney Day 8th March, also reveal that delays in CKD diagnosis are common across countries and there is a lack of awareness of CKD and its symptoms among T2D patients9 – in the UK, half of the respondents knew nothing about CKD prior to their diagnosis, despite the known link between T2D and CKD.9

 

“We are thrilled that finerenone is now made available to eligible adults in England who live with chronic kidney disease associated with type 2 diabetes, a condition that is associated with poor health outcomes for patients and high expenditure to the NHS services when managing the end-stage complications of CKD. We will continue to support the NHS and healthcare professionals to bring this treatment option to benefit more patients,” said Dr Antonio Payano, Senior Bayer Representative, Head of Pharmaceuticals at Bayer UK & Ireland. “Given the rising prevalence of T2D, we are fully committed to raising awareness of CKD among T2D patients and working with physicians on CKD knowledge sharing to help improve diagnosis and empower patients for better outcomes.” 

 

Publication of the NICE guidance on finerenone follows authorisation of Kerendia® (finerenone) (10mg and 20mg) in Great Britain by The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK in March 2022 for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

 

Reporting Side effects:

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects. See www.mhra.gov.uk/yellowcard for how to report side effects, or search for MHRA Yellow Card in google Play or Apple App Store. Adverse events should also be reported to Bayer plc. Tel.: 01182063500, facx 0118 206 3703, Email: pvuk@bayer.com

Bayer Media Contact:

Veronica Yao, +44 (0) 7870 485 926

Email: veronica.yao@bayer.com 

 

Notes to Editors

 

About Kerendia® (finerenone)
Finerenone (BAY 94-8862) is a 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.10-13 MR overactivation is believed to be a major driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.14-16 

 

 

About FIDELIO-DKD

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, event-driven Phase III study investigated the efficacy and safety profile 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 from more than 1,000 sites across 48 countries worldwide.17  

 

About Chronic Kidney Disease associated with Type 2 Diabetes
Chronic kidney disease (CKD) is a common and potentially deadly condition that is generally underrecognised.18 CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.19,20 Up to 40% of all patients with type 2 diabetes develop chronic kidney disease.8,21,22 Despite guideline-directed therapies, patients with CKD associated with T2D remain at high risk of CKD progression and cardiovascular events.23,24,25 It is estimated that CKD affects more than 160 million people with T2D worldwide.19,26,27 CKD associated with T2D is the main cause of end stage kidney disease and often leads to patients requiring dialysis or a kidney transplant to stay alive.23,24 Patients with CKD associated with T2D are three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.28

 

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 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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.co.uk.

 

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. 

 

Kerendia (finerenone) SmPC can be found here:

Kerendia 10mg film coated tablets 

Kerendia 20mg film coated tablets 

 

 

References:  

  1. Finerenone for treating chronic kidney disease in people with type 2 diabetes. NICE Technology Appraisal Guidance [TA877]. Available at: https://www.nice.org.uk/guidance/ta877. 

  2. NICE Final Appraisal Document. Finerenone for treating chronic kidney disease in type 2 diabetes. Available at: https://www.nice.org.uk/guidance/gid-ta10820/documents/final-appraisal-determination-document Last accessed: March 2023.

  3. 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.

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

  5. Erfanpoor S et al. Diabetes, Hypertension, and Incidence of Chronic Kidney Disease: Is There any Multiplicative or Additive Interaction? Int J Endocrinol Metab. 2021 January; 19(1):e101061.

  6. Kidney Research UK. Diabetes. Available at: https://kidneyresearchuk.org/conditions-symptoms/diabetes/. Last accessed: March 2023.

  7. Diabetes UK. Number of people with diabetes reaches 4.7 million. 2019. Available at: https://www.diabetes.org.uk/about_us/news/new-stats-people-living-with-diabetes. Last accessed: March 2023.

  8. Wu B, Bell K, Stanford A et al. Understanding CKD among patients with T2DM: prevalence, temporal trends, and treatment patterns-NHANES 2007-2012. BMJ open diabetes research & care 2016;4: e000154.

  9. The The realities of living with CKD: People with T2D and CKD speak up. Results from a pan-European survey by the European Kidney Patients Federation (EKPF) in collaboration with Bayer AG. EKPF. Available at: https://ekpf.eu/wp-content/uploads/2023/03/EKPF-Designed-Patient-Insights-Report_FINAL.pdf Last accessed: March 2023.

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

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

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

  17. 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: March 2023.

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

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

  20. 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. 

  21. 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.

  22. International Diabetes Federation. Diabetes and Kidneys. Available at: https://idf.org/our-activities/care-prevention/diabetes-and-the-kidney.html. Last Accessed: March 2023.

  23. 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.

  24. Kidney Fund.org. Kidney Failure. Available at: https://www.kidneyfund.org/kidney-disease/kidney-failure/. Last accessed: March 2023.

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

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

  27. Wu B, Bell K, Stanford A et al. Understanding CKD among patients with T2DM: prevalence, temporal trends, and treatment patterns-NHANES 2007-2012. BMJ open diabetes research & care 2016;4: e000154.

  28. 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-0384 / March 2023

 

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