FDA approves Kerendia for heart failure with ejection fraction of 40% or higher

Following priority review, the U.S. Food and Drug Administration approved Bayer’s Kerendia (finerenone) for the treatment of patients with heart failure with left ventricular ejection fraction (LVEF) ≥40%.

Kerendia is a nonsteroidal mineralocorticoid receptor antagonist that selectively blocks overactivation of mineralocorticoid receptors in the heart and kidneys. It targets heart failure with LVEF ≥40%.

Approval was granted based on the results of a Phase III trial (FINEARTS-HF), in which Kerendia, added to standard of care, reduced the relative risk for the composite primary end point—cardiovascular death and total heart failure events—by 16% compared with placebo plus standard of care.

Heart failure events were defined as hospitalizations or urgent visits for heart failure. The treatment effect remained consistent across all prespecified subgroups, regardless of whether patients were using sodium-glucose cotransporter 2 inhibitors.

Adverse events reported in ≥1% of patients (and more frequently than placebo) were elevated potassium levels, hypotension, abnormally low sodium levels, and events related to worsening kidney function.

“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40%—a large and growing group of patients with a poor prognosis,” Chair of the Executive Committee for the FINEARTS-HF study Scott D. Solomon, M.D., from Harvard Medical School and Mass General Brigham in Boston, said in a statement.

“Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”

Copyright © 2025 HealthDay. All rights reserved.

Following priority review, the U.S. Food and Drug Administration approved Bayer’s Kerendia (finerenone) for the treatment of patients with heart failure with left ventricular ejection fraction (LVEF) ≥40%.

Kerendia is a nonsteroidal mineralocorticoid receptor antagonist that selectively blocks overactivation of mineralocorticoid receptors in the heart and kidneys. It targets heart failure with LVEF ≥40%.

Approval was granted based on the results of a Phase III trial (FINEARTS-HF), in which Kerendia, added to standard of care, reduced the relative risk for the composite primary end point—cardiovascular death and total heart failure events—by 16% compared with placebo plus standard of care.

Heart failure events were defined as hospitalizations or urgent visits for heart failure. The treatment effect remained consistent across all prespecified subgroups, regardless of whether patients were using sodium-glucose cotransporter 2 inhibitors.

Adverse events reported in ≥1% of patients (and more frequently than placebo) were elevated potassium levels, hypotension, abnormally low sodium levels, and events related to worsening kidney function.

“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40%—a large and growing group of patients with a poor prognosis,” Chair of the Executive Committee for the FINEARTS-HF study Scott D. Solomon, M.D., from Harvard Medical School and Mass General Brigham in Boston, said in a statement.

“Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”

Copyright © 2025 HealthDay. All rights reserved.