Bayer has received MHRA approval for Kerendia (finerenone) for adults in the UK with symptomatic chronic heart failure and a left ventricular ejection fraction of 40% or above.
The decision covers both heart failure with mildly reduced ejection fraction and heart failure with preserved ejection fraction, two phenotypes that together account for around half of all UK heart failure cases.
Dr Fozia Ahmed, Consultant Cardiologist at Manchester University NHS Foundation Trust, said: “Heart failure with preserved ejection fraction and heart failure with mildly reduced ejection fraction remain among the most challenging forms of heart failure to manage in everyday clinical practice.
They affect a substantial large proportion of patients seen across the NHS and are associated with high rates of hospitalisation and mortality.
“In particular, until recently, treatment options for heart failure with preserved ejection fraction have been limited with few proven benefits. The MHRA approval provides clinicians with an additional licensed option to consider within current heart failure management pathways for a large and historically underserved heart failure patient population in the UK.”
The authorisation is based on the phase 3 FINEARTS-HF study, which enrolled 6,001 adults with symptomatic heart failure and an ejection fraction of at least 40%.
Finerenone reduced the risk of the composite primary endpoint of cardiovascular death and total heart failure events by 16 percent over a median 32 months compared with placebo. Benefits were consistent across all pre-specified subgroups and the treatment was generally well tolerated.
Finerenone is the first non-steroidal mineralocorticoid receptor antagonist to show definitive benefit in a phase 3 study in this patient population. Heart failure affects more than one million people in the UK, with outcomes for those with preserved ejection fraction remaining particularly poor.
