Finerenone: FDA Expands Label to Include Cardiovascular Outcomes Trial Data

Finerenone (Kerendia, Bayer), the first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA), was granted a label expansion this month from the US Food and Drug Administration to include findings from the phase 3 FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), according to a press statement from Bayer.

FIGARO-DKD is the first phase 3 CV outcomes trial conducted in a study population comprised primarily of patients with earlier (stage 1-2) CKD with albuminuria to demonstrate a CV benefit in patients with T2D-associated CKD, according to the company.

Finerenone was approved in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal myocardial infarction (MI) and hospitalization for heart failure (HHF) in adult patients with CKD associated with T2D. This original labeling was based on findings from the pivotal phase 3 FIDELIO-DKD trial.

“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 George Bakris, MD, University of Chicago Medicine and principal investigator of FIDELIO-DKD, in the press statement. “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.”

The double-blind, randomized FIGARO-DKD trial included 7352 patients from study sites in 48 countries. Participants were randomized in a 1:1 ratio to receive therapy with finerenone or a placebo. The primary outcome was time to first occurrence of a composite of death from CV causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Eligibility for the trial included UACR of 30 to <300 mg/g and an eGFR of ≥60 mL/min/1.73m². All patients in FIGARO-DKD were treated with RAS blockade titrated before randomization to the maximum dose on the manufacturer’s label.

FIGARO-DKD investigators reported that, after a median 3.4 years of follow-up, a primary outcome event had occurred among 12.4% (n=458) of participants receiving finerenone and 14.2% (n=519) receiving placebo (HR, 0.87 [95% CI, 0.76-0.98]; P=.03). According to the investigators, this effect was driven mainly by an observed 29% relative reduction in risk of hospitalization for heart failure (HR, 0.71; 95% CI, 0.56-0.90). A reduction in risk for CV death of 10%, they add, also contributed to overall treatment effect (HR, 0.90 [95% CI, 0.74-1.09]).

The US label for finerenone, according to Bayer, now includes data from the phase 3 clinical trial program investigating kidney and cardiovascular outcomes in a population of >13 000 patients withT2D and CKD.

“Our large body of clinical data demonstrates that KERENDIA preserves kidney function and provides dual cardiorenal risk reduction in type 2 diabetes patients with a broad range of chronic kidney disease severity,” said Sameer Bansilal, MD, MS, FACC, Bayer vice president, cardiovascular, US Medical Affairs. “We are committed to equipping clinicians with treatment options…that offer benefits to patients with chronic kidney disease associated with type 2 diabetes as patients work with their treatment teams to manage their disease and slow their chronic kidney disease progression.”