The FDA Will Review Finerenone for Kidney Disease Without Diabetes
The FDA Will Review Finerenone for Kidney Disease Without Diabetes
The U.S. Food and Drug Administration has accepted Bayer’s supplemental New Drug Application (sNDA) for finerenone (Kerendia®) for the treatment of adults with chronic kidney disease (CKD) who do not have diabetes.
The October 8, 2026 filing is supported by results from the Phase III FIND-CKD trial, which evaluated finerenone in adults with non-diabetic CKD receiving standard care. The study showed that finerenone significantly slowed the decline in estimated glomerular filtration rate (eGFR) and reduced the risk of a composite kidney-cardiovascular outcome compared with placebo.
FIND-CKD Provides the Basis for the FDA Filing
FIND-CKD was a randomized, double-blind, Phase III study involving 1,584 adults with chronic kidney disease without diabetes. Participants had an eGFR of 25 to less than 90 mL/min/1.73 m² and albuminuria, and were receiving treatment with a renin-angiotensin system inhibitor.
Patients were assigned to receive finerenone or placebo. The primary endpoint was the annual rate of change in eGFR through Month 32, an established measure used to assess the progression of kidney disease.
The trial included people with different underlying causes of CKD, including hypertension and chronic glomerulonephritis, rather than restricting enrollment to a single disease cause.
Finerenone Slowed the Decline in Kidney Function
At Month 32, the mean annual eGFR decline was 3.3 mL/min/1.73 m² with finerenone compared with 4.0 mL/min/1.73 m² with placebo.
The difference of 0.7 mL/min/1.73 m² per year was statistically significant, with a 95% confidence interval of 0.3 to 1.1 and a P value below 0.001.
The results indicate that finerenone slowed the rate at which kidney function declined in the studied population. The finding is particularly relevant because CKD can progressively reduce kidney function and eventually lead to kidney failure.
Kidney and Cardiovascular Events Were Also Reduced
FIND-CKD also evaluated a composite outcome consisting of a sustained reduction in eGFR of at least 57%, kidney failure, hospitalization for heart failure or cardiovascular death.
Finerenone was associated with a lower risk of this combined kidney-cardiovascular outcome than placebo, with a hazard ratio of 0.77.
The result provides additional evidence that the drug's potential benefits may extend beyond its effect on the measured rate of eGFR decline. However, the individual components of the composite endpoint should be considered separately when interpreting the trial results.
Why Non-Diabetic CKD Is a Significant Market
Finerenone has already established a role in kidney disease associated with type 2 diabetes. Expanding its potential use to people without diabetes would substantially broaden the population that could be treated.
Bayer estimates that 50% to 70% of people with CKD do not have diabetes. In the United States, more than 35 million adults are estimated to have CKD.
Non-diabetic CKD includes a range of underlying conditions, including hypertension and inflammatory kidney diseases. The FIND-CKD results therefore provide data for a broader CKD population than the diabetes-associated population for which finerenone was initially developed.
Finerenone Targets the Mineralocorticoid Receptor
Finerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA). By blocking the mineralocorticoid receptor, the drug is designed to influence pathways involved in inflammation and fibrosis that can contribute to kidney and cardiovascular damage.
The mechanism differs from many conventional treatments used to control blood pressure or reduce albuminuria, giving finerenone a distinct position within kidney-disease treatment.
The FDA currently approves Kerendia for adults with CKD associated with type 2 diabetes and for certain adults with heart failure with a left ventricular ejection fraction of at least 40%.
Hyperkalemia Remains an Important Safety Consideration
As with previous finerenone studies, elevated potassium levels, or hyperkalemia, remain an important safety consideration.
In FIND-CKD, hyperkalemia occurred in 17.0% of patients receiving finerenone compared with 13.3% receiving placebo. The event led to permanent discontinuation of study treatment in 1.5% of finerenone-treated patients and 0.1% of placebo-treated patients.
Serious adverse events overall were similar between the groups, according to Bayer, occurring in 20.9% of patients receiving finerenone and 21.2% receiving placebo.
These findings mean that potassium monitoring and appropriate patient selection will remain important if the FDA expands the drug's indication.
FDA Review Could Broaden Finerenone's Role
The FDA filing represents an important regulatory milestone for Bayer because it seeks to extend finerenone beyond diabetes-associated kidney disease into a much broader CKD population.
The application is supported by a positive Phase III trial rather than an exploratory or early-stage study. Nevertheless, the FDA must now assess the complete evidence package, including efficacy, safety, labeling and the proposed use in patients without diabetes.
If approved, finerenone could become an additional treatment option for adults with CKD whose disease is not driven by diabetes.
A Broader Development Programme for Finerenone
The non-diabetic CKD filing is part of Bayer's broader effort to expand finerenone across cardiovascular and kidney diseases.
The FIND-CKD results add a fifth consecutive Phase III trial in which Bayer says Kerendia met its primary endpoint. The company's finerenone development programme has now evaluated more than 20,000 patients across different heart and kidney disease populations.
For the pharmaceutical market, the potential expansion into non-diabetic CKD could therefore represent an important new indication for an already established medicine rather than the launch of an entirely new therapy.
Sources:
Bentonite
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