Scottish Medicines Consortium approves Bayer’s Kerendia for NHS Scotland

pharmafile | December 2, 2022 | News story | Medical Communications  

The Scottish Medicines Consortium (SMC) has given the green light to Bayer’s Kerendia (finerenone), a chronic kidney disease (CKD) drug for the treatment of adults with CKD associated with type 2 diabetes (T2D).


Finerenone (BAY 94-8862) is a novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA). It blocks the effects of the mineralocorticoid receptor (MR) overreaction, which is thought to be a significant driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.


Finerenone was tested in the FIDELIO-DKD randomised, double-blind, placebo-controlled, multicentre phase 3 trial. Researchers investigated the safety and efficacy of finerenone on kidney and cardiovascular outcomes in 5,734 adult patients with CKD associated with T2D.


Results showed that finerenone “significantly reduced” the risk of kidney disease progression by ≥40%, and renal death by 18%. The secondary cardiovascular endpoint revealed the drug reduced the risk of cardiovascular outcomes, including death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation by 14%.


Professor Patrick Mark, professor of Nephrology, University of Glasgow and honorary consultant nephrologist at 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. 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. 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.”


According to Diabetes UK, T2D is on the rise in Scotland ‒ there was a 40% increase in diagnosed cases between 2008-2018. It is estimated that there are currently 300,000 people living with T2D in Scotland, and 40% of those could eventually develop CKD.


James Spargo

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