Bayer has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for its drug finerenone (KERENDIA), seeking approval for its use in treating heart failure (HF) with a left ventricular ejection fraction (LVEF) of 40% or higher. The application, announced on January 10, 2025, is based on promising results from the Phase 3 FINEARTS-HF study, which showed a significant reduction in cardiovascular death and total heart failure events for patients treated with finerenone.
“Over half of the 6.7 million adults in the U.S. diagnosed with heart failure have an LVEF ≥40%, yet there are few treatment options available for these patients,” said Alanna Morris, MD, MSc, senior medical director at Bayer’s U.S. Medical Affairs. “If approved, finerenone could become an important therapy for these patients, offering improved cardiovascular outcomes.”
Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA), was first approved by the FDA in July 2021 for lowering the risk of kidney disease progression, cardiovascular death, non-fatal myocardial infarction (MI), and heart failure hospitalization in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The drug is also recommended by the American Diabetes Association (ADA) and the European Society of Cardiology (ESC) for improving cardiovascular outcomes and preventing CKD progression in this patient population.
The FINEARTS-HF trial was a randomized, double-blind, placebo-controlled Phase 3 study that evaluated the safety and effectiveness of finerenone in patients with symptomatic heart failure (New York Heart Association [NYHA] class II-IV) and LVEF ≥40%. Approximately 6,000 patients were enrolled and given either finerenone or placebo daily for up to 42 months.
The study met its primary endpoint, demonstrating a 16% relative risk reduction (rate ratio [RR], 0.84; 95% CI, 0.74–0.95; P = .007) in the composite of cardiovascular death and total heart failure events compared to placebo, in addition to standard treatment.
Safety findings showed no new safety concerns compared to previous finerenone trials. Serious adverse events were reported in 38.7% of the finerenone group and 40.5% of the placebo group. Discontinuations due to reasons other than death were similar, with 20% in the finerenone group and 21% in the placebo group.
Hyperkalemia, a known side effect of finerenone, occurred more frequently in the treatment group (10% vs. 4% in the placebo group) and led to hospitalization in 0.5% of patients, compared to 0.2% in the placebo group. However, no deaths occurred due to hyperkalemia, and elevated serum potassium levels (>6 mmol/L) were observed in 3% of finerenone-treated patients versus 1.4% in the placebo group.
Finerenone’s success in FINEARTS-HF marks the first time an nsMRA has achieved a primary cardiovascular endpoint in a Phase 3 trial for patients with heart failure and mildly reduced or preserved ejection fraction.
“This is a major step forward in heart failure treatment,” said Dr. Muthiah Vaduganathan, codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital. “It reinforces that mineralocorticoid receptor antagonists are crucial for all heart failure patients, regardless of ejection fraction, simplifying how we approach heart failure management. Now, sodium-glucose co-transporter 2 (SGLT2) inhibitors and MRAs can be used across the spectrum of ejection fraction.”
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