Bayer Receives U.S. FDA Approval for Finerenone in Heart Failure with Preserved Ejection Fraction
Tuesday, July 15, 2025
Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for finerenone (Kerendia™), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with heart failure with a left ventricular ejection fraction (LVEF) of 40% or greater.
Heart failure remains a major public health concern, affecting over 60 million people worldwide. It is a leading cause of hospitalisation in individuals over 65 and is projected to become even more prevalent in the coming years. The condition often occurs alongside other chronic diseases and carries a high risk of morbidity and mortality.
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist available in 10 mg, 20 mg, and 40 mg doses. It works by targeting the mineralocorticoid receptor and the renin-angiotensin-aldosterone system (RAAS), both of which are key drivers of inflammation, fibrosis, and fluid retention associated with heart failure.
The approval allows its use to reduce the risk of cardiovascular death, hospitalisation for heart failure, and urgent heart failure-related visits in this growing patient population, which currently faces limited therapeutic options.
The number of Americans living with HFpEF is estimated to be 3.7 million, with over 500,000 hospitalisations annually. Many of these patients also manage conditions such as diabetes, hypertension, obesity, and CKD, contributing to higher hospitalisation rates and increased mortality. Within a year of discharge, around 25% of patients are re-hospitalised, and the five-year mortality rate remains high at 75%.
With its new indication, finerenone offers a much-needed treatment option for patients with heart failure and preserved ejection fraction, addressing a significant area of unmet clinical need.
Source: bayer.com
