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# Bayer’s Kerendia Approved for Diabetes Patients
- URL: https://www.fdaweb.com/bayers-kerendia-approved-for-diabetes-patients/
- Published: 2021-07-09T12:00:00.000Z
- Updated: 2026-09-14T17:05:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149679

FDA has approved Bayer’s Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with Type 2 diabetes.

Approval was based on data from a 5,700-patient, placebo-controlled study in adults with chronic kidney disease associated with Type 2 diabetes. “The study compared the two groups for the number of patients whose disease progressed to a composite (or combined) endpoint that included at least a 40% reduction in kidney function, progression to kidney failure, or kidney death,” an [FDA release](https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “Results showed that 504 of the 2,833 patients who received Kerendia had at least one of the events in the composite endpoint compared to 600 of the 2,841 patients who received a placebo.”

The study also compared patients who experienced cardiovascular death, a non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure. “Results showed that 367 of the 2,833 patients receiving Kerendia had at least one of the events in the composite endpoint compared to 420 of the 2,841 patients who received a placebo, with the treatment showing a reduction in the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure,” the agency says.