Bayer AG NAFDA approves Bayer's KERENDIA as the first new CKD treatment for type 1 diabetes in over 30 years, expanding its label.

Bayer announced that the U.S. Food and Drug Administration approved KERENDIA, also known as finerenone, to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease associated with type 1 diabetes, making it the first new treatment approved for this population in more than 30 years. The approval followed the agency's Priority Review of a supplemental New Drug Application and was supported by data from the Phase III FINE-ONE trial, which enrolled 242 adults and showed KERENDIA significantly reduced UACR versus placebo over six months, with reductions of 22% at Month 3 and 28% at Month 6. KERENDIA, a once-daily oral non-steroidal mineralocorticoid receptor antagonist, is the only MRA indicated for adults with chronic kidney disease associated with either type 2 or type 1 diabetes. Approximately 20-30% of people in the U.S. with type 1 diabetes also have chronic kidney disease. Detailed FINE-ONE results were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine.
Bayer AG NAFDA approves Bayer's KERENDIA as the first new CKD treatment for type 1 diabetes in over 30 years, expanding its label.