Finerenone is FDA Approved in Patients with Diabetic Kidney Disease
July 9, 2021 – The FDA announced that finerenone is now approved to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in patients with chronic kidney disease and type 2 diabetes. This is the first non-steroidal mineralocorticoid receptor antagonist (MRA) approved for this indication, with the approval based on the results of the phase 3 FIDELIO-DKD trial, which showed efficacy in both cardiovascular and renal endpoints.
May 18, 2021 – A secondary analysis of the FIDELIO-DKD trial presented at the 2021 American College of Cardiology (ACC) virtual scientific sessions, showed that finerenone reduce the risk of new-onset atrial fibrillation (AF) in patients with DKD. New-onset AFF (atrial fibrillation or atrial flutter) occurred in 82 (3.2%) patients on finerenone and 117 (4.5%) on placebo (hazard ratio: 0.71; 95% confidence interval: 0.53 to 0.94; p = 0.016). The authors mentioned that although this was only an exploratory analysis, it suggests potential beneficial effects of finerenone on AF, which continues to be a growing concern in patients with heart failure, type 2 diabetes, and chronic kidney disease. However, results should be interpreted with caution and additional studies in this area are needed, much of which will be answered by ongoing trials with finerenone.
May 12, 2021 – The manufacturer announced that finerenone met its primary outcome (composite of cardiovascular death and non-fatal CV events, including myocardial infarction, stroke, or hospitalization for heart failure) in the recently-completed FIGARO-DKD trial. The full results of this study are expected to be presented at a major meeting later this year.
The US Food and Drug Administration (FDA) Accepts Priority Review for Finerenone in Diabetic Kidney Disease
January 13, 2021 – The FDA recently accepted a Priority Review for the New Drug Application (NDA) for finerenone for the treatment of chronic kidney disease (CKD) in patients with type 2 diabetes. The NDA submission is based on the results of the FIDELIO-DKD trial, which were published in late 2020 and showed that finerenone decreased the risk of CKD progression and adverse CVD events in this patient population. The priority designation means that the FDA will make a decision on the application within 6 months, as opposed to the 10 months under the standard review process.
Finerenone Lowers the Risk Of CKD Progression in Patients with Type 2 Diabetes – Results from the Fidelio-DKD Trial
December 3, 2020 – Results from the FIDELIO-DKD with finerenone were published in the New England Journal of Medicine. During this trial, which enrolled patients with advanced CKD and T2D, treatment with finerenone reduced the risk of CKD progression (defined as the composite of kidney failure, sustained ≥40% decrease in eGFR from baseline, or renal death) compared to placebo. All patients across groups were treated with optimized renin-angiotensin-aldosterone system (RAAS) inhibitors, and finerenone demonstrated to reduce the risk of DKD progression by an additional 18% over optimal RAAS inhibitor therapy. Additionally, finerenone reduced the risk for adverse cardiovascular events (composite of CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure) by an additional 14% in a key secondary outcome of the study
Finerenone Lowers the Risk of Adverse Cardiovascular Outcomes in Patients with CKD and T2D
November 16, 2020 – An analysis on the effects of finerenone on the individual components of CVD in the FIDELIO-DKD trial was presented at the 2020 American Heart Association Scientific Sessions, and subsequently published in Circulation. The full results of the FIDELIO-DKD trial showed that finerenone decreased the risk of CKD progression and adverse cardiovascular events, and this publication showed that the cardiovascular benefits with finerenone were consistent in patients with or without a history of cardiovascular disease at baseline, suggesting that it can be potentially be used for both primary and secondary cardiovascular prevention in patients with DKD. Patients with finerenone had a lower incidence of the individual CVD components compared to placebo, including CV death, non-fatal MI, and hospitalization for heart failure, however, there was no difference in stroke events between groups.