The FDA has approved Bayer's finerenone (Kerendia) for adults with type 1 diabetes-associated chronic kidney disease, marking the first new treatment for this population in over 30 years. The approval is supported by the phase 3 FINE-ONE trial, which showed a 28% reduction in the urinary albumin-to-creatinine ratio at 6 months. While experts welcome the drug to address a major cause of death affecting up to 30% of type 1 diabetics, clinicians must monitor for side effects like hyperkalemia.
Finerenone FDA approval
- ▪Finerenone is a once-daily oral nonsteroidal mineralocorticoid receptor antagonist designed to lower the urinary albumin-to-creatinine ratio
- ▪The FDA approved finerenone (Kerendia) on September 17, 2026, for the treatment of adults with chronic kidney disease associated with type 1 diabetes
- ▪Finerenone is the first new treatment approved for chronic kidney disease in adults with type 1 diabetes in more than 30 years
FINE-ONE trial results
- ▪The phase 3 FINE-ONE clinical trial of finerenone (Kerendia) in 242 adults with type 1 diabetes and chronic kidney disease showed a 22% decline in urinary albumin-to-creatinine ratio compared with placebo at 3 months
- ▪In the FINE-ONE trial of finerenone (Kerendia) in adults with type 1 diabetes-associated chronic kidney disease, 68.1% of participants receiving finerenone achieved a urinary albumin-to-creatinine ratio reduction of at least 30%, compared with 46.6% of those receiving placebo
Type 1 diabetes CKD burden
- ▪Approximately 20% to 30% of adults in the United States with type 1 diabetes develop chronic kidney disease
- ▪Chronic kidney disease drastically increases the risk of heart complications and kidney failure, making it a leading cause of death for people with type 1 diabetes
Clinical expert perspectives
- ▪Janet McGill, MD, of the Washington University School of Medicine, stated that the FDA's approval of Kerendia for chronic kidney disease associated with type 1 diabetes provides an important new treatment option for a population facing substantial unmet need
- ▪Anne L. Peters, MD, highlighted that concerns about diabetic ketoacidosis with SGLT2 inhibitors may limit the use of those medications in patients with type 1 diabetes and chronic kidney disease
- ▪Anne L. Peters, MD, of the University of Southern California, noted that clinicians must monitor serum potassium levels in patients taking finerenone
Finerenone safety profile
- ▪Finerenone's prescribing information warns of potential worsening renal function in patients with heart failure
- ▪The most common adverse reactions occurring in 1% or more of patients taking finerenone include hyperkalemia, hypotension, and hyponatremia
Drug contraindications
- ▪Finerenone is contraindicated in patients with hypersensitivity to any of its components
- ▪Contraindications for finerenone include adrenal insufficiency, concomitant use of strong CYP3A4 inhibitors, and hypersensitivity to any of its components
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