FDA grants Priority Review to Bayer’s Kerendia (finerenone) for chronic kidney disease in type 1 diabetes, supported by Phase 3 FINE‑ONE trial results published in NEJM and presented at ASN Kidney Week 2025.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Bayer secured FDA Priority Review for its supplemental New Drug Application seeking expanded approval of Kerendia (finerenone) for adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). The filing is supported by positive Phase 3 FINE-ONE (NCT05901831) data published in the New England Journal of Medicine in March 2026 and previously presented as a “Featured High-Impact Clinical Trial” during the Opening Plenary session at ASN Kidney Week 2025.
The FDA’s Priority Review designation shortens the review timeline to approximately six months, positioning Bayer for a potential regulatory decision later in 2026. The designation reflects the urgent need for therapies targeting CKD in T1D, an area with limited treatment options and no approved therapy supported by dedicated late-stage clinical evidence.
Finerenone is a selective nonsteroidal mineralocorticoid receptor antagonist that blocks overactivation of the mineralocorticoid receptor pathway, a major driver of kidney inflammation, fibrosis, and cardiovascular damage. The therapy has already established a differentiated cardiorenal profile through prior Phase 3 programs in CKD associated with type 2 diabetes and heart failure populations, where it reduced kidney disease progression and cardiovascular events.
The Phase 3 FINE-ONE study randomized 242 adults with CKD and T1D across more than 80 sites in nine countries to receive finerenone or placebo alongside standard care. The trial met its primary endpoint, showing a statistically significant 25% reduction in urine albumin-to-creatinine ratio (UACR) over six months compared with placebo (LSGM ratio 0.75; 95% CI 0.65–0.87; p=0.0001).
More patients receiving finerenone achieved at least a 30% reduction in UACR, a threshold associated with slower CKD progression and reduced long-term risk of kidney failure. Safety findings remained consistent with previous finerenone studies, with no new safety signals identified. Hyperkalemia remained an adverse event of special interest and was closely monitored throughout the study.
Dr. Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division, said the FDA review underscores the expanding evidence base supporting finerenone across kidney and cardiovascular diseases. He added that finerenone targets a key biological pathway driving both cardiac and renal damage and could help address a major treatment gap in patients with T1D-associated CKD.
CKD affects nearly 30% of people with T1D, and up to one-quarter may progress to end-stage kidney disease despite standard ACE inhibitor or ARB therapy. Many patients ultimately require dialysis or kidney transplantation, while also facing elevated cardiovascular risk. Bayer has not yet disclosed whether it plans parallel regulatory submissions for the T1D indication outside the United States.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.