FDA Grants Priority Review to Finerenone for Chronic Kidney Disease in Adults With Type 1 Diabetes
Priority review of finerenone for T1D-associated CKD could address a high-burden population with few options beyond renin-angiotensin system blockade and limited recent phase 3 successes.The FDA has accepted a supplemental new drug application (sNDA) and granted priority review to finerenone (Kerendia; Bayer) for the treatment of adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), Bayer announced in a news release.
If approved for this investigational new use, finerenone, a nonsteroidal mineralocorticoid receptor antagonist (MRA), would be the first MRA indicated for adults with T1D and CKD.Bayer’s finerenone has revolutionized outcomes for patients with chronic kidney disease.
Addressing a Significant Disease Burden
Approximately 20% to 30% of people in the United States with T1D also have CKD, placing them at increased risk of cardiovascular events and kidney failure.Despite this significant disease burden, therapeutic advances in this space have been limited.Finerenone is the first investigational treatment since the 1990s to show positive results in a phase 3 study for people living with T1D and CKD.
Finerenone works by selectively and potently blocking mineralocorticoid receptor overactivation in the heart and kidneys, a mechanism distinct from older steroidal MRAs and one that has demonstrated cardiorenal benefit across multiple patient populations in the agent's growing body of clinical evidence.
About the FINE-ONE Trial: Key Findings
The sNDA was supported by the phase 3 FINE-ONE trial (NCT05901831), which showed finerenone significantly reduced urine albumin-to-creatinine ratio (UACR) over 6 months compared with placebo when either is used alongside standard of care for adults with T1D and CKD.The sNDA was also supported by pooled phase 3 data from the FIDELIO-DKD and FIGARO-DKD trials in adult patients with CKD associated with type 2 diabetes (T2D).
FINE-ONE is a pivotal, global, randomized, prospective, double-blind, multicenter phase 3 trial.It enrolled 242 adult participants with the primary objective of demonstrating whether the addition of finerenone, 10 or 20 mg once daily, to standard of care is superior to placebo in reducing UACR over 6 months.UACR is an important clinical marker in this patient population.Elevated UACR is strongly associated with cardiovascular risk and kidney disease progression in multiple patient populations, including those with T1D and T2D.
The trial met its primary end point. Finerenone significantly reduced UACR from baseline over 6 months by approximately 25% compared with placebo in patients with T1D and CKD who received standard of care (95% CI, 0.75 [0.65; 0.87]; P = .0001).These detailed FINE-ONE trial results were presented at the American Society of Nephrology (ASN) Kidney Week 2025 and subsequently published in the New England Journal of Medicine.
