When Was Kerendia (Finerenone) Approved and Started?
Kerendia (finerenone) was approved by the FDA in 2021 for the treatment of chronic kidney disease associated with type 2 diabetes. 1
Clinical Development Timeline
The approval was based on two landmark clinical trials that established finerenone's efficacy:
FIDELIO-DKD (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease) was completed in late 2020, demonstrating significant reduction in kidney disease progression and cardiovascular events in patients with advanced diabetic kidney disease 2
FIGARO-DKD (Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease) followed, assessing cardiovascular outcomes in patients with earlier stages of CKD and type 2 diabetes 2
The FIDELITY pooled analysis combined both trials (N=13,026 patients) with median follow-up of 3.0 years, providing robust evidence across the spectrum of CKD severity 3
Integration into Clinical Guidelines
Following FDA approval in 2021, finerenone was rapidly incorporated into major clinical practice guidelines:
KDIGO 2022 guidelines recognized finerenone as the only nonsteroidal mineralocorticoid receptor antagonist with proven clinical kidney and cardiovascular benefits, recommending it for patients with type 2 diabetes, persistent albuminuria (ACR >30 mg/g), and eGFR ≥25 mL/min/1.73 m² 4
American Diabetes Association 2023 Standards of Care included finerenone as a treatment option for reducing CKD progression and cardiovascular events in diabetic kidney disease 2
2024 ADA Cardiovascular Disease Guidelines further emphasized finerenone's role in preventing progression from asymptomatic (stage A) to symptomatic heart failure in patients with type 2 diabetes and diabetic kidney disease 5
Current Clinical Positioning
Since its approval, finerenone has been positioned as:
An add-on therapy for patients with type 2 diabetes and CKD who have persistent albuminuria despite maximum tolerated doses of ACE inhibitors or ARBs 4, 6
A complementary agent to SGLT2 inhibitors for comprehensive cardiorenal protection, though SGLT2 inhibitors remain the preferred next step after RAS inhibition due to larger effect sizes 6
Particularly valuable for patients who cannot tolerate SGLT2 inhibitors or who remain with albuminuria despite SGLT2 inhibitor therapy 6