FDA Widens Indication of Finerenone for Heart Failure Pts

The FDA has expanded the indications of finerenone to include patients with heart failure with a left ventricular ejection fraction (LVEF) of at least 40%. 

The expanded approval for finerenone, a nonsteroidal mineralocorticoid receptor antagonist developed by Bayer, comes on the strength of the phase 3 FINEARTS-HF trial, published last year in the New England Journal of Medicine.

The study demonstrated that, alongside standard medical care, patients who received the drug achieved a 16% reduction in the risk of cardiovascular death and unplanned or urgent hospitalization due to heart failure. The benefit was driven by a reduction in worsening heart failure events; no significant effect was seen on cardiovascular death.

The FDA initially approved finerenone in 2021 to reduce the risk for cardiovascular death, hospitalization for heart failure, nonfatal myocardial infarction, and kidney complications in adults with chronic kidney disease associated with type 2 diabetes. 

The latest decision expands treatment options for patients with heart failure with mildly reduced or preserved ejection fraction. “[A] large and growing group of patients with a poor prognosis,” said Scott Solomon, MD, a professor of medicine at Harvard Medical School and director of the Clinical Trials Outcomes Center at Mass General Brigham in Boston, in a statement. “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care,” added Solomon, who chaired the executive committee for the trial. 

Patients treated with finerenone had a higher risk for hyperkalemia. In an interview on Medscape at the time, Solomon said “I think we can mitigate the risk for severe hyperkalemia with these drugs.”

Approximately 3.7 million adults in the United States have heart failure with an LEVF of 40% or greater, according to 2024 figures from the Heart Failure Society of America. These patients face high rates of hospitalization, with each additional hospitalization associated with two-fold increased risk of death.

“Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or [cardiovascular] death, and 25% who experience hospitalization are readmitted due to heart failure within one year of discharge. Now, as a core pillar of treatment, KERENDIA can help patients reduce these risks,” Alanna Morris-Simon, MD, MSc, senior medical director of US Medical Affairs at Bayer, said in a statement. 

Finerenone is available in 10-, 20-, and 40-mg tablets. The drug is contraindicated for patients with hypersensitivity to the medication, adrenal insufficiency, or those taking strong CYP3A4 inhibitors. 

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