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

 The FDA approved finerenone (Kerendia) for adults with type 1 diabetes-associated chronic kidney disease (CKD), marking the first new treatment option for this population in more than 30 years, Bayer announced on Thursday.

The selective non-steroidal mineralocorticoid receptor antagonist is indicated to lower the urinary albumin-to-creatinine ratio (UACR), which reduces the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease.

Overactive mineralocorticoid receptors drive kidney disease progression and heart damage through inflammatory, fibrotic, metabolic, and hemodynamic mechanisms.

"For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression," said Janet McGill, MD, of the Washington University School of Medicine in St. Louis, in a statement. "The approval of Kerendia to reduce UACR ... provides an important new treatment option for a population that has continued to face substantial unmet need."

Despite using standard treatments for glucose and blood pressure control, about 30% of adults with type 1 diabetes develop CKD. This drastically increases the risk of heart complications and kidney failure, making CKD a leading cause of death for people with type 1 diabetes.

The approval was based on the phase III FINE-ONE study, which demonstrated that finerenone combined with standard of care reduced the UACR by 22% at 3 months and 28% at 6 months compared with placebo.

Additionally, 68.1% of participants receiving finerenone achieved a UACR reduction of at least 30% compared with 46.6% of those receiving placebo. The American Diabetes Association recognizes a 30% UACR reduction as a key threshold associated with slower CKD progression.

Finerenone's safety profile in type 1 diabetes was largely consistent with previous findings in type 2 diabetes-associated CKD, for which the drug was approved in 2021. It later gained an indication in 2025 for treating adults with symptomatic chronic heart failure with a left ventricular ejection fraction of 40% or greater.

The most common adverse reactions (occurring in 1% or more of patients) with finerenone include hyperkalemia, hypotension, and hyponatremia. The prescribing information warns of potential worsening renal function in patients with heart failure. Contraindications include adrenal insufficiency, concomitant use of strong CYP3A4 inhibitors, and hypersensitivity to any of its components.

https://www.medpagetoday.com/nephrology/type1diabetes/123038