FDA Approves Bayer's Kerendia for Chronic Kidney Disease in Type 1 Diabetes, First New Option in Over 30 Years
核心洞察
The FDA has approved Bayer (搜索)'s Kerendia (finerenone) to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease (搜索) associated with type 1 diabetes (搜索).
The approval, granted under Priority Review, marks the first new treatment in more than three decades for this specific patient population.
Supporting data came from the Phase III FINE-ONE trial, where Kerendia reduced UACR by 22% at month three and 28% at month six versus placebo.
The U.S. Food and Drug Administration has approved Bayer (搜索)'s Kerendia (finerenone) for adults with chronic kidney disease (搜索) (CKD) associated with type 1 diabetes (搜索) (T1D), making it the first new treatment in more than three decades for this population. The decision followed the agency's Priority Review of Bayer's supplemental New Drug Application.
Kerendia is a non-steroidal mineralocorticoid receptor (搜索) antagonist (MRA) designed to reduce urinary albumin-to-creatinine ratio (UACR), a key marker of kidney damage. The approval is expected to slow CKD progression and reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease (搜索) in this population. With the decision, Kerendia becomes the only non-steroidal MRA indicated for adults with CKD associated with either type 2 diabetes (搜索) (T2D) or T1D.
FINE-ONE Trial Results
The approval is supported by data from the Phase III FINE-ONE trial (NCT05901831), a pivotal, global, randomized, prospective, double-blind, placebo-controlled, multicenter study in adult patients with CKD associated with T1D. The trial enrolled 242 adult participants and was designed to demonstrate whether adding Kerendia at 10 mg or 20 mg once daily to standard of care was superior to placebo in reducing UACR over six months, averaged across months three and six.
Kerendia significantly reduced UACR compared with placebo over six months, with reductions observed as early as month three and sustained through month six. At month three, Kerendia reduced UACR relative to placebo by 22%, and at month six the reduction reached 28%.
Safety and tolerability were consistent with existing evidence for Kerendia in adults with CKD associated with T2D. The rate of treatment-emergent adverse events was 47.1% for patients treated with Kerendia versus 49.2% for placebo, while treatment-emergent serious adverse events occurred in 11.8% of the Kerendia group versus 11.5% of the placebo group. Hyperkalemia, an adverse event of special interest, was observed more frequently with Kerendia (10.1%) than placebo (3.3%), with treatment discontinuation due to hyperkalemia occurring in 1.7% of Kerendia patients and none of the placebo group.
Detailed FINE-ONE results were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine.
Bridging Evidence From Type 2 Diabetes
Approval was also supported by additional Phase III data from the FIDELIO-DKD and FIGARO-DKD trials in adults with CKD associated with T2D. In those trials, reductions in UACR with Kerendia were associated with improved kidney outcomes, and together with the FINE-ONE results, the evidence supports using UACR to bridge Kerendia's established kidney outcomes data from CKD associated with T2D to patients with CKD associated with T1D.
"For more than three decades, people with chronic kidney disease (搜索) and type 1 diabetes (搜索) have had limited options to address the risk of kidney disease progression," said Dr. Janet McGill, professor of medicine in the division of endocrinology, metabolism, and lipid research at Washington University School of Medicine in St. Louis, and co-chair of the study's executive committee. "The approval of Kerendia to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need."
Approximately 20-30% of people in the U.S. with T1D also have CKD, placing them at elevated risk of kidney disease progression and kidney failure. Until now, that population has had limited treatment options specifically studied and approved for their condition.
An Expanding Label
The T1D indication extends Kerendia's existing U.S. label. Kerendia is already approved in the U.S. for reducing risks of kidney disease progression and cardiovascular complications in adults with CKD associated with T2D. In July 2025, Kerendia received FDA approval to reduce the risk of cardiovascular death, hospitalization for heart failure (搜索), and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.