FDA Approves Kerendia, First Type 1 CKD Drug

The FDA approved Bayer’s Kerendia (finerenone) for adults with chronic kidney disease associated with type 1 diabetes, making it the first new treatment for this indication in more than 30 years. The decision was supported primarily by the Phase 3 FINE-ONE trial, in which Kerendia reduced urinary albumin-to-creatinine ratio—a marker of kidney damage—by 25% compared with placebo after six months. Bayer said the reduction is expected to slow kidney-function decline and lower the risk of end-stage kidney disease, addressing a significant unmet need among people with type 1 diabetes, roughly one-quarter to one-third of whom develop CKD. Kerendia was previously approved for certain kidney and cardiovascular risks in adults with CKD associated with type 2 diabetes and now has a third U.S. indication.