Bayer announced on 14 July that US regulator the Food and Drug Administration (FDA) has approved finerenone for treating heart failure (HF) in adults with left ventricular ejection fraction (LVEF) ≥40%. This makes finerenone the only non-steroidal mineralocorticoid receptor antagonist (nsMRA) approved in the US for both type 2 diabetes-related chronic kidney disease (CKD) and HF with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). The approval was based on Phase III FINEARTS-HF trial data showing finerenone significantly reduced cardiovascular death and HF hospitalisations while maintaining a favourable safety profile.

Finerenone works by targeting mineralocorticoid receptor (MR) overactivation, addressing key pathological mechanisms like fibrosis in HFpEF/HFmrEF. With approximately 3.7 million patients affected by HF with LVEF≥40% in the US – a population facing high rehospitalisation and mortality rates – this approval addresses a major unmet need. Regulatory submissions for this indication are also under review in China, the EU and Japan.

According to PharmCube's NextBiopharm database, there are currently 82 HFpEF treatments approved globally. Click here to request a free trial for NextBiopharm.