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 T2D^2,3

Reading, 30^th 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, yet many people do not understand it. 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:

▼ 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.: 0118 206 3500, Fax: 0118 206 3703, Email: pvuk@bayer.com