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

The full results of this study can be accessed here.

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.

The full results of this study can be accessed here.

Additional Resources

1. Staging, Monitoring and Prognosis of Chronic Kidney Disease
2. The Kidney Disease: Improving Global Outcomes (KDIGO) 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (CKD)
3. Cardiorenal Protection With the Newer Antidiabetic Agents in Patients with Diabetes and Chronic Kidney Disease: A Scientific Statement From the American Heart Association
4. American Diabetes Association – 2021 Standards of Medical Care in Diabetes