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The new indication would include adults with heart failure with a left ventricular ejection fraction (LVEF) of 40% or higher, such as mildly reduced or preserved LVEF.
The FDA accepted the supplemental new drug applications (sNDA) and granted a priority review designation to finerenone (Kerendia; Bayer) for the treatment of adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of 40% or higher, such as mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).1 The regulatory submission was based on positive results from the phase 3 FINEARTS-HF trial (NCT04435626),2 which were published in The New England Journal of Medicine.3
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Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that was initially approved by the FDA in July 2021 to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for HF in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. In this population, the nsMRA has been recommended to improve cardiovascular outcomes and reduce the risk of CKD progression by the American Diabetes Association, as well as reduce cardiovascular and kidney failure risk in addition to standard of care by the European Society of Cardiology.1
Approximately 6.7 million US adults live with HF, a syndrome in which symptoms and signs can result from structural or functional impairment of the ventricular filling or ejection of blood. Approximately 55% of these patients have a LVEF of 40% or higher, and most also have multiple comorbidities, such as obesity, diabetes, hypertension, and CKD.1
“People with HFmrEF or HFpEF face substantial challenges in diagnosis, treatment, and follow-up care,” Robert Perkins, MD, MPH, FACP, vice president, US Medical Affairs, Bayer, in a news release. “In fact, a 2024 report on HF trends and outcomes published in the Journal of Cardiac Failure showed that in patients with HFpEF, 5-year mortality was 75.7%. The FDA’s decision to grant priority review designation to our application underlines the significant unmet need these patients face.”1
FINEARTS-HF (NCT04435626) was a randomized, double-blind, placebo-controlled, multicenter, event-driven phase 3 trial that investigated the efficacy and safety of finerenone when used to reduce the risk of cardiovascular death and HF events in patients who were diagnosed with symptomatic HF with LVEF of 40% or greater (measured by local imaging measurement within the last 12 months). Patients were randomly assigned to receive finerenone (n = 3003; maximum dose of 20 mg or 40 mg once daily) or matching placebo (n = 2998), in addition to usual therapy. These patients also received diuretic treatment for at least 30 days prior to randomization.1-3
The primary outcome was a composite of total worsening HF events (with an event defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes, which was assessed up to 42 months. The components of the primary outcome and safety were also assessed.2,3
Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 patients in the finerenone group, and 1283 primary-outcome events occurred in 719 patients in the placebo group (rate ratio: 0.84 [95% CI, 0.74-0.95]; P =.007). The total numbers of worsening HF events were 842 and 1024 in the finerenone and placebo groups, respectively (rate ratio: 0.82 [95% CI, 0.71-0.94]; P =.006). Additionally, patients receiving placebo (8.7%) were more likely to die from cardiovascular causes compared with those receiving finerenone (8.1%; HR: 0.93 [95% CI, 0.78-1.11]).3
Trial Name: Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF)
ClinicalTrials.gov ID: NCT04435626
Sponsor: Bayer
Completion Date: June 14, 2024
Further, there were no new safety signals identified during this trial compared with those seen in previous studies. Serious adverse events were comparable between treatment groups, occurring in 38.7% (n = 1157) and 40.5% (n = 1213) of patients in the finerenone and placebo groups, respectively. Discontinuation of the trial drug for reasons other than death was also similar between groups (finerenone: 20.4%, n = 611; placebo: 20.6%, n = 616) in the placebo group.1
“[Finerenone] is already an established pillar of therapy to improve cardiovascular outcomes for patients with type 2 diabetes and CKD, and Bayer is committed to investigating [finerenone’s] benefits in other patient populations, including HF,” said Alanna Morris-Simon, MD, MSc, senior medical director of US Medical Affairs, Bayer, in the news release. “If approved for patients with HF with LVEF of 40% [or above], [finerenone] will be an important new treatment option with the potential to become a pillar of therapy to provide cardiovascular benefits in another patient population with unmet need.”1
