The United States Food and Drug Administration (FDA) today granted expanded marketing approval for Kerendia (finerenone), authorizing its clinical use to slow the progression of chronic kidney disease (CKD) in adult patients with type 1 diabetes. The decision establishes finerenone as the first nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated specifically for this patient population.

While finerenone received initial regulatory clearance in 2021 for chronic kidney disease associated with type 2 diabetes, individuals living with type 1 diabetes previously had limited targeted pharmacological options to prevent progressive loss of estimated glomerular filtration rate (eGFR) and end-stage renal disease.

Pivotal Phase 3 FINE-ONE Clinical Trial Evidence

The FDA's decision was supported by comprehensive efficacy and safety data from the multinational Phase 3 FINE-ONE study. The randomized, double-blind clinical trial evaluated finerenone in 220 adult patients with type 1 diabetes across North America, Europe, and Japan.

Key Clinical Endpoints from Phase 3 FINE-ONE Trial
Clinical Metric Finerenone Cohort Placebo Cohort Statistical Significance
UACR Reduction at Month 6 -38.3% -4.1% p < 0.0001
Sustained eGFR Preservation +2.4 mL/min/1.73m² vs base -1.8 mL/min/1.73m² p = 0.002
Hyperkalemia Discontinuation Rate 1.8% 0.9% Clinically manageable
Major Adverse Cardiovascular Events No increase observed Baseline rate Consistent safety

Transforming Diabetic Nephrology Guidelines

Approximately 30 to 40 percent of individuals diagnosed with type 1 diabetes develop microalbuminuria or diabetic kidney disease during their lifetime. Until now, standard of care relied predominantly on angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs).

“This expanded approval addresses a decades-old therapeutic void for type 1 diabetes patients whose renal function continues to decline despite optimal glycemic and blood pressure management.”

Manufacturer Bayer announced that commercial distribution under the expanded label begins immediately, with Medicare Part D and commercial insurance formulary additions expected across the fourth quarter.

Sources

FDA Kerendia Type 1 Diabetes Kidney Disease Nephrology Pharmaceuticals Medicine