The U.S. Food and Drug Administration (FDA) approved Bayer’s Kerendia (finerenone) to treat chronic kidney disease (CKD) in adults with type 1 diabetes (T1D). This authorization marks the first new treatment option for this patient group in more than three decades.
Results from the Phase III FINE-ONE clinical trial supported the approval. The study showed Kerendia significantly reduced the urinary albumin-to-creatinine ratio (UACR), a primary marker of kidney damage.
This decision represents the third U.S. label expansion for Kerendia. The drug is already approved to treat CKD in patients with type 2 diabetes and certain types of heart failure.