Bayer Submits Finerenone Application to FDA for Treatment of Heart Failure

Credit: US Food and Drug Administration

Bayer has announced the submission of a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for finerenone (KERENDIA) for the treatment of heart failure (HF) with a left ventricular ejection fraction (LVEF) ≥40%.¹

Announced on January 10, 2025, regulatory submission was based on positive findings from the Phase 3 FINEARTS-HF study, demonstrating finerenone’s statistically significant reduction on the composite of cardiovascular death and total HF events.

“More than half of the approximately 6.7 million adults in the US diagnosed with HF have an LVEF ≥40%, but there are limited guideline-directed treatment options available for these patients,” Alanna Morris, MD, MSc, senior medical director of US Medical Affairs at Bayer, said in a statement. “If approved, [finerenone] could serve as a new pillar of therapy in this disease and improve cardiovascular outcomes for patients with high unmet medical need.”

Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) approved by the FDA in July 2021 to lower the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction (MI, and HF-hospitalization in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).²

Guidelines from the American Diabetes Association (ADA) and the European Society of Cardiology (ESC) have recommended finerenone to improve cardiovascular outcomes and reduce the risk of CKD progression in adults with CKD associated with T2D.¹ Despite the high prevalence of adults in the US with HF and LVEF ≥40%, there are limited guideline-directed medical therapy options.

FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase 3 trial measuring the effect and safety of finerenone for reducing cardiovascular death and HF events in patients with a diagnosis of symptomatic HF (New York Heart Association [NYHA] class II-IV) with an LVEF of ≥40%. Approximately 6000 patients were randomized to receive once-daily finerenone or placebo for up to 42 months.

Analysis showed that FINEARTS-HF met its primary endpoint, achieving a 16% (rate ratio [RR], 0.84; 95% CI, 0.74–0.95; P = .007) relative risk reduction of the composite primary endpoint of CV death and total (first and recurrent) HF events, compared with placebo, in addition to a prescribed treatment regimen.³

Safety data in FINEARTS-HF found no new signals compared with those seen in previous finerenone studies. Serious adverse events were comparable between treatment groups, with reports in 38.7% of the finerenone group and 40.5% of the placebo group. Drug discontinuations for reasons other than death were similar between the finerenone (20%) and placebo (21%) groups.

Hyperkalemia was reported more frequently in finerenone-treated patients (10%), compared with the placebo group (4%). It led to hospitalization in 0.5% of the finerenone group versus 0.2% of the placebo group, with no cases resulting in death. Serum potassium levels >6 mmol/L were observed in 3% of the finerenone group and 1.4% of the placebo group.

With these results, finerenone became the first nsMRA to meet a primary cardiovascular endpoint in a Phase 3 study investigating patients with HF with mildly reduced or preserved ejection fraction (LVEF ≥40%).

"I do believe that FINEARTS-HF was an important clinical advance. I think it substantiated that MRAs broadly, are important for all patients with HF, irrespective of their ejection fraction. I think this greatly simplifies how we think about HF management today, and that sodium-glucose co-transporter 2 (SGLT2) inhibitors and MRAs now can be used across the spectrum of ejection fraction," Muthiah Vaduganathan, MD, MPH, codirector of Center for Cardiometabolic Implementation Science at Brigham and Women's Hospital, told HCPLive at AHA 2024.

References

1. _{Bayer submits Supplemental New Drug Application to U.S. FDA seeking new indication for Kerendia® (finerenone) in patients with heart failure with left ventricular ejection fraction of ≥40%. Business Wire. January 10, 2025. Accessed January 10, 2025. https://www.businesswire.com/news/home/20250109213827/en/Bayer-Submits-Supplemental-New-Drug-Application-to-U.S.-FDA-Seeking-New-Indication-for-KERENDIA%C2%AE-finerenone-in-Patients-with-Heart-Failure-with-Left-Ventricular-Ejection-Fraction-of-%E2%89%A540?utm_campaign=shareaholic&utm_medium=linkedin&utm_source=socialnetwork.}
2. _{Campbell P. Finerenone (Kerendia) approved for chronic kidney disease associated with type 2 diabetes. HCP Live. May 19, 2023. Accessed January 10, 2025. https://www.hcplive.com/view/finerenone-kerendia-approved-chronic-kidney-disease-associated-with-type-2-diabetes.}
3. _{Campbell P. Finearts-hf: Finerenone could find role as second pillar in HFMREF/HFPEF. HCP Live. September 2, 2024. Accessed January 10, 2025. https://www.hcplive.com/view/finearts-hf-finerenone-could-find-role-as-second-pillar-in-hfmref-hfpef.}