The US Food and Drug Administration (FDA) has approved Bayer’s Kerendia (finerenone) for adults with heart failure and left ventricular ejection fraction (LVEF) of 40% or higher, expanding the drug’s reach to a broader patient population following a priority review.

“People with heart failure with LVEF ≥40% face very real risks of hospitalization or cardiovascular death, even with current treatments,” said Dr. Alanna Morris-Simon, senior medical director of US Medical Affairs at Bayer. “Kerendia can now help reduce these risks as a core pillar of treatment.”

The newly approved use builds on Kerendia’s earlier indication for chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Since 2021, the drug has been part of an expanding cardio-renal-metabolic care portfolio.

Kerendia is part of a class of drugs called non-steroidal mineralocorticoid receptor antagonists (nsMRAs). Unlike older steroidal MRAs, it selectively blocks mineralocorticoid receptor overactivation in the heart and kidneys, a process linked to inflammation and fibrosis.

Trial Data That Drove the Decision

The FDA’s approval is based on results from the Phase III FINEARTS-HF trial (NCT04435626), published in the New England Journal of Medicine. The trial enrolled about 6,000 patients with symptomatic heart failure and LVEF ≥40%, randomizing them to receive Kerendia or placebo on top of standard heart failure treatments.

The drug is part of an expanding cardio-renal-metabolic care portfolio, is approved for CKD associated with type 2 diabetes. reduced the combined risk of CV death and total heart failure events—defined as hospitalizations or urgent heart failure visits—by 16% compared to placebo (relative risk 0.84; 95% confidence interval: 0.74–0.95; p=0.007).

“This group of patients has historically been difficult to treat effectively,” said Dr. Scott D. Solomon, professor of medicine at Harvard Medical School and chair of the trial’s executive committee. “Finerenone offers a new pillar of comprehensive care that could shift outcomes for these individuals.”

Importantly, the benefit was consistent across all prespecified subgroups, including patients already taking sodium-glucose cotransporter 2 (SGLT2) inhibitors, a newer class of heart failure drugs.

The FINEARTS-HF trial found Kerendia’s safety profile to be in line with earlier studies. Common side effects occurring in more than 1% of patients included hyperkalemia (high potassium levels), hypotension (low blood pressure), hyponatremia (low sodium), and events related to worsening kidney function.

Hyperkalemia occurred in 9.7% of Kerendia patients compared to 4.2% with placebo, while hypotension rates were 7.6% versus 4.7%.

“These risks are not insignificant, but they are manageable within the context of routine clinical care,” noted Solomon.

Building a Broader Evidence Base

The FINEARTS-HF trial is part of Bayer’s larger MOONRAKER program, which the company says is among the largest heart failure study initiatives globally. With over 15,000 patients enrolled across studies, MOONRAKER aims to strengthen the evidence base for finerenone’s use in diverse heart failure populations.

The MOONRAKER program includes FINEARTS-HF as well as the ongoing investigator-sponsored Phase III trials, namely REDEFINE-HF (NCT06008197), CONFIRMATION-HF (NCT06024746), and FINALITY-HF (NCT06033950). 

In parallel, Bayer’s THUNDERBALL program continues to explore Kerendia in CKD patients without diabetes. The program includes completed studies FIDELIO-DKD and FIGARO-DKD, as well as ongoing Phase III trials such as FIND-CKD (NCT05047263) for patients with non-diabetic CKD, FIONA (NCT05196035) for children (1-18 years) with CKD and proteinuria, FIONA-OLE (NCT05457283) for children (1-18 years) with CKD and proteinuria, and FINE-ONE (NCT05901831) for patients with CKD and type 1 diabetes.