FDA grants priority review to finerenone for adults with type 1 diabetes and chronic kidney disease based on FINE-ONE data.
The US Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for finerenone (Kerendia®; Bayer) and granted Priority Review for use in adults with
“The FDA’s acceptance of this application underscores the clinical importance of our ongoing program for KERENDIA, and growing evidence base, across broad patient populations in cardiovascular and kidney diseases,” Carolina Aldworth, MD, MSc, executive medical director at Bayer, said in the release. “With five Phase III trials now having achieved their primary endpoints — including
Key Facts
If approved,
FINE-ONE enrolled 242 adults and compared once-daily finerenone 10 mg or 20 mg with placebo over 6 months. The trial’s primary objective was reduction in urine albumin-to-creatinine ratio (UACR), a biomarker associated with kidney disease progression and cardiovascular risk. Investigators reported finerenone significantly reduced UACR compared with placebo, with a least-squares mean change of 0.75 (95% CI, 0.65-0.87; P < .001).¹
Safety findings were generally consistent with prior experience with finerenone in CKD associated with type 2 diabetes (T2D), according to the company. Treatment-emergent adverse events occurred in 47.1% of finerenone-treated participants and 49.2% of placebo-treated participants. Serious treatment-emergent adverse events were reported in 11.8% and 11.5%, respectively. Hyperkalemia, a known risk with MRAs and a labeled warning for finerenone, occurred more often with finerenone than placebo (10.1% vs 3.3%); discontinuation due to hyperkalemia occurred in 1.7% and 0%, respectively.¹
The FDA grants Priority Review to applications for medicines that, if approved, would provide significant improvements in safety or effectiveness for the treatment, diagnosis, or prevention of serious conditions. The designation shortens the agency’s review goal compared with standard review, although the announcement did not include a target action date.²
CKD remains a clinically important complication of T1D. In US adults with T1D, recent estimates cited by Bayer suggest approximately 20% to 30% also have CKD.³ These patients face increased risk for kidney failure and cardiovascular events, and treatment options specifically supported by late-stage trial data in T1D-associated CKD have been limited.
Finerenone is a nonsteroidal MRA that blocks mineralocorticoid receptor overactivation in the heart and kidneys. The drug is already FDA approved to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with T2D. It is also approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction of at least 40%.⁴
The sNDA was also supported by pooled phase 3 data from FIDELIO-DKD and FIGARO-DKD in adults with CKD associated with T2D, according to Bayer. However, for clinicians considering the potential T1D indication, FINE-ONE’s use of UACR rather than a hard kidney or cardiovascular outcome is an important interpretive point. The 6-month duration and modest sample size limit conclusions about long-term kidney failure, cardiovascular events, and durability of albuminuria reduction.
If the application is approved, prescribing will likely require the same attention to potassium and kidney function monitoring already emphasized in finerenone labeling. Current US prescribing information advises measuring serum potassium and estimated glomerular filtration rate before initiation, avoiding initiation when serum potassium is greater than 5 mEq/L, and monitoring potassium periodically during treatment.⁴
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