Finerenone sNDA Submitted to FDA for Heart Failure with Preserved Ejection Fraction
核心洞察
Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for finerenone to treat heart failure (搜索) patients with LVEF ≥40%.
The sNDA is based on the Phase III FINEARTS-HF trial, which demonstrated a 16% reduction in cardiovascular death and heart failure (搜索) events.
Finerenone is a non-steroidal mineralocorticoid receptor (搜索) antagonist (nsMRA) already approved for chronic kidney disease (搜索) in type 2 diabetes (搜索).
Bayer has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for finerenone (Kerendia) for the treatment of heart failure (搜索) (HF) in patients with a left ventricular ejection fraction (LVEF) of 40% or greater (LVEF ≥40%). This submission aims to expand the drug's indication to include a significant portion of heart failure patients who currently have limited treatment options.
The sNDA is based on data from the Phase III FINEARTS-HF trial, a randomized, double-blind, placebo-controlled study involving approximately 6,000 patients. The trial investigated the efficacy and safety of finerenone in reducing the risk of cardiovascular death and heart failure (搜索) events in patients with symptomatic heart failure (New York Heart Association class II-IV) and LVEF ≥40%. All patients were also receiving diuretic treatment for at least 30 days prior to randomization.
The FINEARTS-HF trial met its primary endpoint, demonstrating a statistically significant 16% relative risk reduction (rate ratio, 0.84; 95% CI, 0.74 to 0.95; P = 0.007) in the composite outcome of cardiovascular death and total (first and recurrent) heart failure (搜索) events (hospitalizations for HF or urgent HF visits) compared to placebo, when added to a patient’s prescribed treatment regimen. The results of the study were presented at the European Society of Cardiology (ESC) Congress and published in The New England Journal of Medicine.
Addressing Unmet Needs in Heart Failure
Heart failure (搜索) is a complex clinical syndrome affecting approximately 6.7 million adults in the U.S., with about 55% having an LVEF ≥40%. Despite its prevalence, guideline-directed medical treatment options for these patients are limited, often leaving them to manage multiple comorbidities such as obesity, diabetes, hypertension, and chronic kidney disease (搜索) (CKD).
Alanna Morris, M.D., MSc, Senior Medical Director of U.S. Medical Affairs at Bayer, stated, “More than half of the approximately 6.7 million adults in the U.S. diagnosed with heart failure (搜索) have an LVEF ≥40%, but there are limited guideline-directed treatment options available for these patients. If approved, Kerendia could serve as a new pillar of therapy in this disease and improve cardiovascular outcomes for patients with high unmet medical need.”
Finerenone: A Non-Steroidal MRA
Finerenone is a non-steroidal mineralocorticoid receptor (搜索) antagonist (nsMRA) that was initially approved by the FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for HF in adult patients with chronic kidney disease (搜索) (CKD) associated with type 2 diabetes (搜索) (T2D). It is recommended by both the American Diabetes Association (ADA) and the European Society of Cardiology (ESC) for improving cardiovascular outcomes and reducing the risk of CKD progression in adults with CKD associated with T2D.
Safety Profile
In the FINEARTS-HF trial, the safety profile of finerenone was consistent with previous studies. Serious adverse events were comparable between the treatment groups, with 38.7% in the finerenone group and 40.5% in the placebo group. Discontinuation of the trial drug for reasons other than death was also similar between the groups (20.4% for finerenone vs. 20.6% for placebo).
Increases in creatinine and potassium levels were more frequent in patients receiving finerenone compared to placebo. Investigator-reported hyperkalemia (搜索) occurred in 9.7% of finerenone-treated patients versus 4.2% in the placebo group. Serum potassium levels >6 mmol/L were observed in 3% of the finerenone group compared to 1.4% in the placebo group. While hyperkalemia was more common with finerenone, it rarely led to hospitalization (0.5% vs. 0.2% in the placebo group), and no cases resulted in death.
The MOONRAKER Program
The FINEARTS-HF trial is part of the MOONRAKER clinical trial program, one of the largest HF trial programs to date, involving over 15,000 patients. This program aims to establish a comprehensive understanding of finerenone across a broad spectrum of patients and clinical settings in heart failure (搜索).