Bayer receives MHRA authorisation in Great Britain for Kerendia® (finerenone) as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes

Bayer receives MHRA authorisation in Great Britain for Kerendia^®  (finerenone) as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes

• Kerendia^® (finerenone), the first oral, non-steroidal, selective mineralocorticoid receptor antagonist,¹ is indicated for the treatment of chronic kidney disease (CKD) (stage 3 and 4 with albuminuria) associated with type 2 diabetes (T2D) in adults²
• UK authorisation 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

Reading, 9^th March 2022 – The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has authorised the use of Kerendia^® (finerenone) (10mg or 20mg) in Great Britain, an oral, first-in-class non-steroidal, selective mineralocorticoid receptor (MR) antagonist,¹ for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.² Kerendia is already approved in the U.S. and the European Union (including Northern Ireland), and regulatory filings in other regions are underway or planned.  

The authorisation 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, published in the New England Journal of Medicine (NEJM) in October 2020.¹

In FIDELIO-DKD, patients were randomised in a 1:1 ratio to receive finerenone (2,866) or placebo (2,868). 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.¹ 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].¹ Finerenone was generally tolerated in the study.¹ 

Professor David Wheeler, Professor of Kidney Medicine at University College London and Honorary Consultant Nephrologist at the Royal Free London NHS Foundation Trust said: “Chronic kidney disease associated with type 2 diabetes is the most common cause of kidney failure and often leads to patients requiring dialysis or a kidney transplant to stay alive.^4,5 There remains a critical medical need to protect these patients by delaying kidney disease progression and reducing their risk of cardiovascular events, which is why this is welcoming news for patients living with the condition. Physicians in the UK now have another new treatment option to help improve kidney outcomes in this patient population.”  

“We are pleased to bring finerenone, the only drug that has been developed exclusively for CKD, to eligible adults in the UK who live with chronic kidney disease associated with type 2 diabetes,” said Dr. Antonio Payano, Senior Bayer Representative, Head of Pharmaceuticals at Bayer UK & Ireland. “Chronic kidney disease associated with type 2 diabetes not only ultimately has a debilitating impact on patients’ lives, but managing end-stage kidney disease consequently also places a huge financial burden on the already stretched NHS services. Timely detection and management are therefore vital to ensure the best outcomes for patients and that kidney health is carefully monitored in those at-risk.⁶ We believe the availability of finerenone provides UK physicians with a much-needed new management option to help alleviate the huge burden of chronic kidney disease on patients and the healthcare system.”

Despite guideline-directed therapies, many patients with CKD associated with T2D progress to kidney failure or premature death.^4,7,8 In the UK, it is estimated that over 4.4 million people are living with type 2 diabetes, including almost one million undiagnosed,⁹ and as many as 1.76 million people (40%) could eventually develop CKD in T2D,¹⁰ which is now the leading cause of kidney failure in the UK.¹¹

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.¹ Based on an absolute between-group difference of 2.4% [95% CI, 0.3–4.5] at 36 months, the number needed to treat to prevent a key secondary CV event was 42 [95% CI, 22–397].¹