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News
The FDA has approved finerenone (Kerendia) to treat chronic kidney disease (CKD) in adults with type 1 diabetes — marking the first drug approved for this indication in more than three decades. Based on the phase 3 FINE-ONE trial, the once-daily pill significantly reduced a key marker of kidney damage compared to placebo. Kerendia was previously approved for CKD linked to type 2 diabetes back in 2021.
The FDA has approved finerenone (Kerendia, Bayer) to lower urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease associated with type 1 diabetes — a milestone that fills a treatment gap persisting for over 30 years. The once-daily oral nonsteroidal mineralocorticoid receptor antagonist targets a key pathway involved in kidney inflammation and fibrosis.
The approval was based on results from the phase 3 FINE-ONE trial, which demonstrated meaningful kidney protection with a safety profile comparable to prior studies in type 2 diabetes patients. The findings were also published in The New England Journal of Medicine.
By the Numbers:
Why it matters: Adults with type 1 diabetes and CKD have had virtually no targeted therapies for decades. This approval expands Kerendia's label — which already covers CKD in type 2 diabetes and certain heart failure types — and offers a much-needed new option for a population facing serious risk of kidney disease progression.
