FDA Grants Priority Review to Kidney Drug for Type 1 Diabetes Patients

Dr. Rachel Mendez MD, Medical Science Writer

✨ Why this is good news

Chronic kidney disease is a serious complication that can affect people with type 1 diabetes, often with limited treatment options.

First treatment for type 1.Before this, no drug was specifically approved for chronic kidney disease in adults with type 1 diabetes. KERENDIA could become the first, filling a decades-long gap in care.
Priority review speeds access.The FDA granted Priority Review, meaning a decision will come in 6 months instead of the standard 10. This could get the drug to patients much faster.
New mechanism of action.KERENDIA is a non-steroidal mineralocorticoid receptor antagonist, a different approach than existing kidney treatments. This offers a fresh option for patients who may not have responded to older therapies.
Hope for an underserved group.People with type 1 diabetes and kidney disease have seen few therapeutic advances in decades. This approval would finally give them a dedicated treatment option.

The U.S. Food and Drug Administration has granted Priority Review to a drug that could become the first treatment specifically approved for adults with type 1 diabetes and chronic kidney disease, offering new hope to a patient group that has seen few therapeutic advances in decades.

Bayer announced that the FDA accepted its supplemental application for KERENDIA (finerenone), a non-steroidal mineralocorticoid receptor antagonist, and will fast-track its review. If approved, it would be the first medication of its class indicated for adults with type 1 diabetes and chronic kidney disease. The decision is based on the FINE-ONE trial, the first Phase III study since the 1990s to show positive results for this specific patient population. The trial enrolled 242 adults and found that adding finerenone to standard care significantly reduced a key marker of kidney damage over six months.

KERENDIA works by selectively blocking the mineralocorticoid receptor, a protein that when overactivated can contribute to inflammation and scarring in the heart and kidneys. The drug is already approved for patients with type 2 diabetes and chronic kidney disease to lower the risk of cardiovascular death, heart failure hospitalization, and kidney failure. In July 2025, it also received FDA approval for adults with heart failure with preserved ejection fraction. The broader clinical program, called FINEOVATE, now includes 10 Phase III studies across heart and kidney conditions.

The FDA grants Priority Review to drugs that offer significant improvements over existing options. A decision on the supplemental application is expected in the coming months. If approved, KERENDIA could fill a critical gap for the estimated one in three adults with type 1 diabetes who develop chronic kidney disease, a condition that often progresses silently and carries high risks of cardiovascular complications and kidney failure. Researchers and patient advocates hope this marks the beginning of more targeted therapies for a community that has long been underserved by new drug development.

This article is for informational purposes only and does not constitute medical advice. The information presented is based on published research and official announcements. Always consult a qualified healthcare professional before making any medical decisions.