For UK Medical and Trade Media
Bayer receives acceptance of Kerendia®▼(finerenone) by Scottish Medicines Consortium (SMC) for treating adult patients with chronic kidney disease associated with type 2 diabetes in NHS Scotland
- Kerendia®▼(finerenone)is now available through NHS Scotland for the treatment of chronic kidney disease (CKD) (stage 3 and 4 with albuminuria) associated with type 2 diabetes (T2D) in adults1
- SMC acceptance 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 T2D2,3
Reading, 30th November 2022 - Bayer announced that Kerendia®▼(finerenone) (10mg and 20mg), an oral, first-in-class non-steroidal, selective mineralocorticoid receptor (MR) antagonist,2 has been accepted for use within NHS Scotland by The Scottish Medicines Consortium (SMC) for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.1
SMC acceptance is based on the results of the pivotal Phase III FIDELIO-DKD study investigating the efficacy and safety of finerenone on kidney and cardiovascular outcomes in 5,734 adult patients with CKD associated with T2D.2 The study showed that finerenone significantly reduced the risk of the primary composite renal outcome of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥ 40% from baseline over a period of at least four weeks, or renal death by 18% (relative risk reduction, absolute risk reduction 3.3%, HR 0.82 [95% CI, 0.73-0.93; p=0.0014]) 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 guideline-directed therapy.2 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].2 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.2
Finerenone was generally tolerated in the study.2
Professor Patrick Mark, Professor of Nephrology, University of Glasgow, Honorary Consultant Nephrologist, Queen Elizabeth University Hospital, said: “this is welcome news for people living with chronic kidney disease associated with type 2 diabetes mellitus (T2DM) in Scotland and their clinicians. CKD associated with T2DM is the most common single cause of kidney failure globally and represents the fastest rising cause of kidney failure in Scotland.4,5 Patients living with CKD associated with T2DM are approximately three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.6 The SMC’s decision means many diabetic patients will now have access to a treatment option that will protect them by delaying kidney disease progression.”
Dr Kevin Fernando, GP Partner North Berwick Health Centre, GPwSI CVRM, Scottish Lead Primary Care Diabetes Society, said: “management of chronic kidney disease associated with type 2 diabetes is more effective if started early. Chronic kidney disease often progresses silently and unpredictably, with many symptoms not apparent until the disease is well advanced.7,8 Timely detection is therefore vital to ensure the best outcomes for patients.9 People with type 2 diabetes should regularly be monitored by their doctor for the earliest signs of kidney disease. Early testing in those at-risk can help detect CKD and tell us how quickly it will progress.”
“Chronic kidney disease is a common, burdensome complication of type 2 diabetes that can be silent for years. Even when blood glucose levels and blood pressure are well-controlled, a significant number of patients experience CKD progression and associated cardiovascular events,” said Dr Gemma Currie, Honorary Clinical Senior Lecturer, School of Cardiovascular & Metabolic Health, University of Glasgow. “Management of CKD in patients with T2D is important in diabetes care to preserve kidney function to reduce the risk of end-stage kidney disease, cardiovascular events, and mortality.”
Despite guideline-directed therapies, many patients with CKD associated with T2D progress to kidney failure or premature death.4,10,11 Approximately 40% of people living with type 2 diabetes could eventually develop CKD in T2D,12 which is now the leading cause of kidney failure in the UK.13 The prevalence of type 2 diabetes in Scotland has increased by 40% in the past decade; over 300,000 people are now living with type 2 diabetes, including those yet to be diagnosed, among Scotland's population of 5.4 million.14
Alison Railton, Head of policy and external affairs, Kidney Research UK, said: “in Scotland, chronic kidney disease affects around 3.2% of the population15; yet for many years, treatment options have been limited, particularly in people living with this condition who also have type 2 diabetes. We are pleased that a new treatment option has become available for eligible patients.”
Penny Shaddick, Head of Patient Access, Bayer UK, said: “we are thrilled that finerenone, the only mineralocorticoid receptor antagonist that has been developed exclusively for CKD, is made available to eligible adults in Scotland who live with chronic kidney disease associated with type 2 diabetes, a condition that not only has a debilitating impact on patients’ lives, but which also burdens the NHS services when managing the end-stage complications of CKD. We will continue to support the NHS to bring the new treatment option to benefit more patients.”
Reporting of side effects:
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Notes to Editors
Finerenone (BAY 94-8862) is a 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 models16-19 MR overactivation is believed to be a major driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.20-22 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 The Phase III study programme, FINEOVATE*, currently comprises five Phase III studies, FIDELIO-DKD24, FIGARO-DKD25, FIND-CKD26, FINEARTS-HF27 and FIONA28.
*The FINEOVATE study programme comprises studies which included use of finerenone in patients outside its currently approved indication in the UK. This was in clinical trial setting only. Bayer does not encourage off-licence use of medications. Please always refer to the local prescribing information before prescribing.
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 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.24
About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a common and potentially deadly condition that is generally underrecognised.29 CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.30,31 Up to 40% of all patients with type 2 diabetes develop chronic kidney disease.4,32,33 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.30,34,12
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.
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.
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.
- Advice on finerenone (Kerendia) from Scottish Medicines Consortium. Available at: https://www.scottishmedicines.org.uk/medicines-advice/finerenone-kerendia-full-smc2486/. Last accessed: December 2022.
- 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.
- Filippatos G, et al. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation 2021. 143:540–552
- 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.
- Scottish Renal Registry. Annual report 2022. A Management Information release for Scotland. Public Health Scotland 2022
- 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.
- Khan Y H, et al; J Coll Physicians Surg Pak. 2018;28:960-966.
- Zhong J, et al; Am J Physiol Renal Physiol. 2017;375-384. 1
- KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney International. 2013. 3, 1-150.
- Anders, H J, et al. CKD in diabetes: diabetic kidney disease versus nondiabetic kidney disease. Nature Reviews Nephrology. 2018. 14, 361–377.
- Thomas M C, et al. Diabetic kidney disease. Nature Reviews Disease Primers. 2015; 1:15018.
- 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.
- Kidney Research UK. Diabetes. Available at: https://kidneyresearchuk.org/conditions-symptoms/diabetes/. Last accessed: November 2022.
- Diabetes UK. Number of people with type 2 diabetes in Scotland increases by 40% in a decade. Available at: https://www.diabetes.org.uk/in_your_area/scotland/news/increase-diabetes. Last accessed: November 2022.
- Kidney disease: Scottish data. Chronic kidney disease - prevalence. Available at: https://www.scotpho.org.uk/health-wellbeing-and-disease/kidney-disease/data/scottish-data/. Last accessed: November 2022.
- 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.
- Kolkhof P et al. Nonsteroidal antagonists of the mineralocorticoid receptor. Current Opinion in Nephrology and Hypertension. 2015. 24, 417-424.
- 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.
- 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.
- Bauersachs J, et al. Mineralocorticoid receptor activation and mineralocorticoid receptor antagonist treatment in cardiac and renal diseases. Journal of Hypertension. 2015. 65, 257-263.
- Barrera-Chimal J, Girerd S, Jaisser F. Mineralocorticoid receptor antagonists and kidney diseases: pathophysiological basis. Kidney Int 2019; 96:302–319.
- Buonafine M, Bonnard B, Jaisser F. Mineralocorticoid receptor and cardiovascular disease. Am J Hypertens 2018; 31:1165–1174.
- 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.
- 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: November 2022.
- 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: November 2022.
- 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: November 2022.
- 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: November 2022.
- Bayer global press release on 15th November 2021. Bayer extends clinical development program for finerenone with Phase III study in children and adolescents with chronic kidney disease.
- Breyer MD et al. Developing Treatments for Chronic Kidney Disease in the 21st Century. Seminars in Nephrology. 2016. 36(6), 436–447.
- International Diabetes Federation. IDF Diabetes Atlas Ninth Edition. 2019.
- 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.
- 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.
- International Diabetes Federation. Diabetes and Kidneys. Available at: https://idf.org/our-activities/care-prevention/diabetes-and-the-kidney.html. Last Accessed: November 2022.
- Zheng Y et al. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nature Reviews Endocrinology. 2018. 14(2), 88-98.
Date of preparation: December 2022