The U.S. Food and Drug Administration has approved Bayer’s once-daily oral medication Kerendia to reduce the risk of disease progression in adults with chronic kidney disease associated with type 1 diabetes. According to Bayer and reporting by Healio, the approval makes the drug, chemically known as finerenone, the first drug approved for this specific indication in more than 30 years.
FDA Approval Based on Phase 3 FINE-ONE Trial Data
The regulatory decision rests on data from the phase 3 FINE-ONE clinical trial, which evaluated the nonsteroidal mineralocorticoid receptor antagonist in adult patients. According to Healio’s coverage of the trial results published in The New England Journal of Medicine, participants who took 10 mg to 20 mg of finerenone daily experienced a 34% decrease in their urinary albumin-to-creatine ratio from baseline at six months. By comparison, the placebo group saw a 12% reduction.
Safety and tolerability findings during the FINE-ONE trial aligned closely with previous studies involving type 2 diabetes populations. Treatment-emergent adverse events and serious adverse events occurred at similar rates across both the finerenone and placebo study arms.
Addressing a Decades-Long Treatment Gap in Type 1 Diabetes
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 trial’s executive committee, noted the significance of the regulatory milestone in a press release. “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 stated, adding that the new indication provides a vital treatment option for an underserved patient population.
This expands the clinical footprint of finerenone, which received initial FDA approval in 2021 to reduce risks of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and heart failure hospitalization for adults with chronic kidney disease linked to type 2 diabetes. Bayer also secured an additional FDA approval in 2025 for finerenone to treat heart failure with mildly reduced or preserved left ventricular ejection fraction.