FDA Approves Finerenone for Broader Heart Failure Treatment

The US Food and Drug Administration (FDA) has granted new approval for Bayer’s finerenone (Kerendia) with a new indication to treat adults with heart failure and a left ventricular ejection fraction (LVEF) of 40% or higher.

This significant update expands the drug's indication beyond patients with chronic kidney disease and type 2 diabetes to also include potential new patients with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).

The FDA’s decision was based on the results of the FINEARTS-HF Phase III trial, which enrolled approximately 6,000 symptomatic patients with heart failure and an LVEF ≥?40%. Over a median follow-up of up to 42 months, finerenone use was associated with 16% lower cardiovascular death and total heart failure events compared to placebo. Treatment benefit was found in all subgroups, including those patients who were on SGLT2 inhibitors.

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The safety profile of finerenone was consistent with previously identified safety indications. Hyperkalemia, hypotension and decline of renal function were reported more frequently in the finerenone group, but within anticipated limits. No new safety signals were identified in the finerenone cohort.

Given that there are an estimated 3.7 million adults in US with heart failure and an LVEF ≥?40%, this represents an important milestone in the care of HFmrEF/HFpEF. This new indication solidifies Kerendia as an option in care as versatile cardio-renal therapy, and a much-needed option for clinicians to care for patients in HF with unmet needs.