Bayer’s Kerendia has received US FDA approval for adults with chronic kidney disease associated with type 1 diabetes, opening a new treatment option for a patient population facing a significant risk of disease progression.

 

The approval for Kerendia (finerenone), a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), covers finerenone at 10mg and 20mg doses and allows its use to reduce urinary albumin-to-creatinine ratio (UACR), a marker associated with kidney damage. 

 

The reduction is expected to lower the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with CKD associated with type 1 diabetes.

 

The need is substantial. About 30% of people with type 1 diabetes in the US develop chronic kidney disease, putting them at increased risk of kidney failure and cardiovascular events. Despite recommended treatments aimed at controlling blood glucose and blood pressure, many patients continue to face kidney disease progression and cardiovascular complications.

 

“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, 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 study’s Executive Committee. 

 

"The approval of Kerendia to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”

 

Bayer said the approval represents a major expansion of Kerendia’s use and addresses what it describes as a longstanding gap in treatment for people with CKD associated with type 1 diabetes.

 

“Today’s approval in the U.S. marks an important advance for people living with chronic kidney disease associated with type 1 diabetes—a serious and often under-recognized condition. 

 

"As the first new FDA-approved treatment option in more than 30 years for this patient population, Kerendia reflects Bayer’s commitment to addressing significant unmet needs and bringing meaningful new treatment options to patients,” said Christine Roth Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.