First New Drug Approved in Decades for Type 1 Diabetes-Related Kidney Disease

Federal health regulators have approved a new medication to treat chronic kidney disease associated with type 1 diabetes, marking the first fresh therapeutic option for this patient population in more than 30 years. Drug manufacturer Bayer announced the milestone following clearance from the U.S. Food and Drug Administration (FDA).

The newly approved medication, finerenone, marketed under the brand name Kerendia, is classified as a selective non-steroidal mineralocorticoid receptor antagonist. According to the announcement, the drug is indicated to lower the urinary albumin-to-creatinine ratio in adults. By reducing this ratio, the therapy aims to lower the risk of sustained estimated glomerular filtration rate decline and progression toward end-stage kidney disease.

Medical experts note that overactive mineralocorticoid receptors contribute significantly to the progression of renal damage and cardiac complications by driving inflammatory, fibrotic, metabolic, and hemodynamic pathways. Despite modern standard treatments focused on glucose and blood pressure management, approximately 30% of adults living with type 1 diabetes ultimately develop chronic kidney disease. This complication substantially elevates the danger of heart failure and kidney failure, making renal disease a leading cause of mortality among individuals with type 1 diabetes.

Janet McGill, MD, of the Washington University School of Medicine in St. Louis, highlighted the historical lack of advancements in a public statement. She noted that for more than three decades, individuals managing chronic kidney disease alongside type 1 diabetes have faced severely restricted choices to combat the progression of renal impairment. She added that the introduction of Kerendia provides an essential new avenue for a patient demographic facing ongoing unmet medical needs.

Clinical Trial Findings and Efficacy

The regulatory approval was grounded in data gathered from the phase III FINE-ONE clinical trial. Results from the study showed that administering finerenone alongside standard care reduced the urinary albumin-to-creatinine ratio by 22% at the three-month mark and by 28% at six months, compared to a placebo.

Furthermore, trial data revealed that 68.1% of study participants who received finerenone achieved a reduction in their urinary albumin-to-creatinine ratio of at least 30%. In comparison, only 46.6% of patients in the placebo group reached that same benchmark. The American Diabetes Association identifies a 30% reduction in this specific ratio as a crucial clinical threshold linked directly to a slower progression of chronic kidney disease.

Safety Profile and Considerations

The safety evaluation for finerenone in patients with type 1 diabetes aligned closely with previous safety data established during its evaluation for type 2 diabetes-associated chronic kidney disease, for which the drug originally received approval in 2021. The medication later secured an additional indication in 2025 aimed at treating adults diagnosed with symptomatic chronic heart failure who exhibit a left ventricular ejection fraction of 40% or greater.

Clinical prescribing information outlines potential adverse reactions. The most frequent side effects, occurring in at least 1% of patients, include:

• Hyperkalemia
• Hypotension
• Hyponatremia

Additionally, product labeling warns of a potential for worsening renal function in patients being treated for heart failure. Contraindications for the medication include adrenal insufficiency, hypersensitivity to any of the drug’s components, and the simultaneous use of strong CYP3A4 inhibitors.

Patients diagnosed with type 1 diabetes and associated kidney concerns are encouraged to consult their healthcare providers to discuss whether this newly available treatment option aligns with their individualized care plans.

Source: MedPage Today