FDA Expands Kerendia’s Use to Treat Common Form of Heart Failure

The FDA approved Kerendia (finerenone) for the treatment of heart failure with a left ventricular ejection fraction (LVEF) of 40% or greater in adults, making it the first non-steroidal mineralocorticoid receptor antagonist (MRA) approved for this population.

Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic kidney disease (CKD) associated with type 2 diabetes. This new approval extends its use to a broader patient population.

A nurse is listening to a patient's heartbeat. © Bayer

This population includes patients without chronic kidney disease, allowing Kerendia to benefit a wider group of heart failure patients who previously had limited targeted treatment options beyond standard care.

Today’s approval for this form of heart failure—known as heart failure with mildly reduced or preserved ejection fraction (HFmrEF and HFpEF)—affects about 3.7 million adults in the U.S. Even with existing treatments, patients with LVEF of 40% or greater face serious risks, including frequent hospitalizations and high rates of cardiovascular (CV) death, according to Bayer.

Each hospitalization can more than double the risk of death from cardiovascular causes.

Kerendia works by selectively blocking mineralocorticoid receptor overactivation in the heart and kidneys. This approach is designed to address harmful pathways that contribute to the progression of heart failure. The FDA granted the approval following a priority review of Bayer’s supplemental New Drug Application (sNDA).

The monthly wholesale cost for Kerendia is $686.70, though the out-of-pocket cost varies depending on insurance coverage. Bayer has stated that support programs may be available for those without insurance or whose plans do not cover the drug.

The approval is based on findings from the FINEARTS-HF phase 3 clinical trial. In this large, randomized, double-blind study of roughly 6,000 patients, Kerendia—when added to standard care—reduced the combined risk of CV death and heart failure-related events by 16% compared to placebo. These events included hospitalizations or urgent visits due to heart failure. The results were consistent regardless of whether patients were also taking SGLT2 inhibitors.

Scott D. Solomon, M.D., professor of medicine at Harvard Medical School and chair of the study’s executive committee, said based on results that were found in the clinical trial, Kerendia “can become a new pillar of comprehensive care.”

The safety profile of Kerendia was in line with previous uses.

In the FINEARTS-HF trial, side effects occurring in 1% or more of patients and more frequently than in the placebo group included hyperkalemia (high potassium), hypotension (low blood pressure), hyponatremia (low sodium) and worsening kidney function. While these risks exist, they were considered manageable within the context of the drug's demonstrated benefits.

The trial is part of Bayer’s broader MOONRAKER program, which includes more than 15,000 heart failure patients globally. This initiative is one of the largest heart failure research programs to date and is designed to gather comprehensive data on Kerendia across a wide range of clinical settings, according to a press release by Bayer.

In addition to the MOONRAKER program, Bayer continues to evaluate Kerendia through its FINEOVATE clinical trial portfolio, which includes studies in both heart failure and CKD.

This expanding evidence highlights Kerendia’s role as a key component of cardiovascular care.

With this new FDA approval, Kerendia becomes a significant new option for patients living with a complex and increasingly common form of heart failure—offering another option for potentially better outcomes and fewer hospital visits.