• Kerendia reduced urinary albumin-to-creatine ratio at 6 months for adults with CKD associated with type 1 diabetes in FINE-ONE.
• The drug was previously approved for CKD associated with type 2 diabetes in 2021.

The FDA has approved finerenone as a therapy to lower urinary albumin-to-creatinine ratio among adults with chronic kidney disease associated with type 1 diabetes, Bayer announced.

Finerenone (Kerendia, Bayer), a once-daily oral nonsteroidal mineralocorticoid receptor antagonist, received approval for adults with CKD associated with type 1 diabetes based on data from the phase 3 FINE-ONE trial. As Healio previously reported from ASN Kidney Week, adults who received 10 mg to 20 mg of once-daily finerenone had a 34% decrease in urinary albumin-to-creatine ratio from baseline to 6 months compared with a 12% reduction for the placebo group (P = .0001). Safety and tolerability data for finerenone in the trial was similar to what was observed in previous studies conducted in the type 2 diabetes population. Rates of treatment-emergent adverse events and serious adverse events were similar between the finerenone and placebo groups. The results of FINE-ONE were also published in The New England Journal of Medicine.

As Healio previously reported, finerenone was approved by the FDA in 2021 to reduce risk for sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction and hospitalization for heart failure among adults with CKD associated with type 2 diabetes. The FDA’s new approval for CKD associated with type 1 diabetes makes finerenone the first drug approved for the indication in more than 30 years, according to Bayer.

In 2025, the FDA also approved finerenone for the treatment of HF with mildly reduced or preserved left ventricular ejection fraction.

“For more than 3 decades, people with CKD and type 1 diabetes have had limited options to address the risk of kidney disease progression,” 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 FINE-ONE trial’s executive committee, said in a press release. "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.”