WHIPPANY, N.J.– The U.S. Food and Drug Administration has approved KERENDIA® (finerenone) to treat adults with heart failure with left ventricular ejection fraction (LVEF) ≥40%, Bayer announced Monday. The approval follows a Priority Review of the company’s supplemental New Drug Application and marks a major expansion of KERENDIA’s use beyond chronic kidney disease associated with type 2 diabetes.
KERENDIA, a non-steroidal mineralocorticoid receptor antagonist (nsMRA), is now the first and only MRA approved by the FDA for this category of heart failure, which includes both mildly reduced (HFmrEF) and preserved (HFpEF) ejection fractions. The expanded indication offers new hope for the approximately 3.7 million adults in the U.S. affected by this condition, a population still at high risk for cardiovascular death and hospitalization despite existing guideline-directed treatments.
The FDA’s decision is based on data from the Phase III FINEARTS-HF trial, which showed that KERENDIA, when added to standard therapy, reduced the composite risk of cardiovascular death and total heart failure events by 16% compared to placebo. The effect was consistent across all subgroups, including those receiving SGLT2 inhibitors.
“Finerenone can become a new pillar of comprehensive care,” said Dr. Scott D. Solomon, Professor of Medicine at Harvard Medical School and Chair of the FINEARTS-HF Executive Committee. “This approval expands treatment options for a large and growing group of patients with a poor prognosis.”
The safety profile of KERENDIA in the trial was consistent with previous studies. Adverse events occurring in more than 1% of patients and more frequently than with placebo included hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), hyponatremia (1.9% vs 0.9%), and events related to worsening renal function (18% vs 12%).
“Even with current therapies, patients with heart failure and LVEF ≥40% face high rates of hospitalization or cardiovascular death,” said Dr. Alanna Morris-Simon, Senior Medical Director of U.S. Medical Affairs at Bayer. “With this new indication, KERENDIA becomes a core treatment option for helping reduce those risks.”
KERENDIA was first approved in July 2021 for patients with chronic kidney disease associated with type 2 diabetes. This latest approval broadens its cardiovascular benefit to a much wider patient population, underscoring its role in treating both kidney and heart disease.
Detailed results from the FINEARTS-HF study were published in the New England Journal of Medicine.
