As reported on Healio, the U.S. Food and Drug Administration has approved finerenone (Kerendia; Bayer) for adults with chronic kidney disease (CKD) associated with type 1 diabetes, marking the first new therapy approved for this indication in more than three decades.
The expanded indication is supported by findings from the phase 3 FINE-ONE trial, which evaluated the efficacy and safety of the once-daily oral nonsteroidal mineralocorticoid receptor antagonist in patients with CKD and type 1 diabetes. Investigators reported that patients treated with finerenone at doses of 10 mg or 20 mg daily experienced a 34% reduction in urinary albumin-to-creatinine ratio (UACR) from baseline to 6 months, compared with a 12% reduction among those receiving placebo. The difference between groups was statistically significant (P = .0001).
Researchers also found that the safety profile of finerenone in the type 1 diabetes population was generally consistent with previous studies conducted in patients with type 2 diabetes. Rates of treatment-emergent adverse events and serious adverse events were comparable between the finerenone and placebo arms. Results from the FINE-ONE study were also published in The New England Journal of Medicine.
The FDA has approved finerenone to lower urinary albumin-to-creatinine ratio for adults with chronic kidney disease associated with type 1 diabetes. Bayer noted that the decision makes Kerendia the first therapy approved specifically for this patient population in more than 30 years.
Kerendia previously received FDA approval in 2021 for adults with CKD associated with type 2 diabetes. That approval was based on evidence demonstrating reductions in the risk of sustained decline in estimated glomerular filtration rate, progression to end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure.
The medication has also gained additional indications in recent years. In 2025, the FDA approved finerenone for the treatment of heart failure in patients with mildly reduced or preserved left ventricular ejection fraction.
Commenting on the approval, Janet McGill, MD, MA, FACE, FACP, professor of medicine in the Division of Endocrinology, Metabolism and Lipid Research at Washington University School of Medicine in St. Louis and co-chair of the FINE-ONE executive committee, emphasized the longstanding need for additional therapeutic options in this population.
“For more than 3 decades, people with CKD and type 1 diabetes have had limited options to address the risk of kidney disease progression,” McGill said in a Bayer statement. “The approval of Kerendia to reduce urinary albumin-to-creatine ratio, which is expected to slow CKD progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”
