FDA Expands Finerenone Approval for Heart Failure Patients With Preserved Ejection Fraction

 In a significant development for heart failure (HF) treatment, the US Food and Drug Administration (FDA) has approved finerenone (Kerendia) for patients with mildly reduced or preserved left ventricular ejection fraction (LVEF ≥ 40%). This marks a major expansion of mineralocorticoid receptor antagonist (MRA)-based therapy beyond the traditional scope of patients with reduced ejection fraction.

Backed by FINEARTS-HF Trial Results

The FDA’s decision is grounded in the phase III FINEARTS-HF trial, which demonstrated that finerenone—a nonsteroidal MRA—significantly reduces the risk of cardiovascular death and worsening HF events compared to placebo. The trial focused on patients with LVEF ≥ 40%, a group historically underserved by MRA therapies.

Previous landmark studies such as RALES, EMPHASIS-HF, and TOPCAT had shown benefits for steroidal MRAs like spironolactone and eplerenone, but only in patients with LVEF < 40%. FINEARTS-HF now fills a critical gap by extending therapeutic options to a broader HF population.

Key Findings From the Trial

• Primary Endpoint: Finerenone achieved a 16% relative risk reduction in cardiovascular death and total HF events.

• Main Driver: The reduction was primarily due to fewer HF events.

• Safety Profile:

  • Overall adverse event rates were similar between finerenone and placebo.

  • Higher incidence of hyperkalemia (9.7% vs 4.2%) and elevated creatinine (2.0% vs 1.2%) in the finerenone group.

• No Interaction: The drug’s efficacy was consistent regardless of concurrent use of sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Impact on Patient Care

This approval is poised to benefit an estimated 3.7 million adults in the US living with HF and preserved or mildly reduced ejection fraction. With its proven efficacy and manageable safety profile, finerenone may become a cornerstone in the comprehensive management of HF in this population.

A Growing Role in Cardiovascular and Renal Health

Finerenone was previously approved in 2021 for patients with chronic kidney disease associated with type 2 diabetes, based on the FIGARO-DKD and FIDELIO-DKD trials. The latest FDA decision further solidifies its role in treating complex cardio-renal conditions.