The prescribing information for Kerendia® (finerenone) has been updated to include data from the FIGARO-DKD cardiovascular (CV) outcomes study (ClinicalTrials.gov: NCT02545049) in patients with chronic kidney disease (CKD) and type 2 diabetes.

Kerendia is a nonsteroidal selective mineralocorticoid receptor antagonist. It is currently approved to reduce the risk of sustained estimated glomerular filtration (eGFR) decline, end stage kidney disease, CV death, nonfatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with CKD associated with type 2 diabetes based on data from the phase 3 FIDELIO-DKD study (ClinicalTrials.gov Identifier: NCT02540993).

In the phase 3 FIGARO-DKD trial, patients were randomly assigned to receive finerenone (n=3683) or placebo (n=3666) and were followed for 3.4 years. All patients received standard of care therapy, including a maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB). Compared with FIDELIO-DKD, patients in the FIGARO-DKD trial had a higher baseline eGFR (62% had an eGFR ≥60mL/min/1.73m2) and a lower median urinary albumin-to-creatinine ratio (308mg/g).

Findings showed that when compared with placebo, treatment with finerenone reduced the incidence of the primary composite endpoint of CV death, nonfatal MI, nonfatal stroke or hospitalization for heart failure by 13% (hazard ratio [HR], 0.87 [95% CI, 0.76-0.98]; P =.026).

While an effect on CV death (10% risk reduction; HR, 0.90 [95% CI, 0.74-1.09]) contributed to the composite outcome, it was mainly driven by an effect on hospitalization for heart failure (29% risk reduction; HR, 0.71 [95% CI, 0.56-0.90]). The treatment effect was found to be consistent across subgroups, including patients with and without pre-existing CV disease.

“The FIDELIO-DKD and FIGARO-DKD studies demonstrated Kerendia’s dual cardiorenal risk reduction in patients with chronic kidney disease associated with type 2 diabetes,” said Professor George Bakris, MD, University of Chicago Medicine and principal investigator of FIDELIO-DKD. “This label update reaffirms Kerendia as a fundamental pillar in the treatment algorithm to improve cardiovascular and renal outcomes in patients with chronic kidney disease associated with type 2 diabetes.”

Kerendia is supplied as 10mg and 20mg tablets.

References

  1. Bayer’s Kerendia® (finerenone) receives updated label to include findings from phase III FIGARO-DKD cardiovascular outcomes study in patients with chronic kidney disease and type 2 diabetes. News release. September 1, 2022. https://www.businesswire.com/news/home/20220901005853/en/Bayer%E2%80%99s-KERENDIA%C2%AE-finerenone-Receives-Updated-Label-to-Include-Findings-From-Phase-III-FIGARO-DKD-Cardiovascular-Outcomes-Study-in-Patients-With-Chronic-Kidney-Disease-and-Type-2-Diabetes
  2. Kerendia. Package Insert. Bayer; 2022. Accessed September 2, 2022. https://labeling.bayerhealthcare.com/html/products/pi/Kerendia_PI.pdf