Bayer has announced that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA).
The approval was based on results from the phase III FINEARTS-HF trial, which showed that, on top of standard of care, Kerendia achieved a 16% relative risk reduction of the composite primary endpoint of cardiovascular death and total heart failure events, defined as hospitalisation for HF or an urgent HF visit, compared to placebo on top of standard of care (relative risk [RR]=0.84, 95% confidence interval [CI]: 0.74–0.95, p=0.007). The treatment effect was consistent across all prespecified subgroups including with or without SGLT2i use.
Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys, taking aim at HF with LVEF ≥40% from a different angle.
The overall safety profile of Kerendia was consistent across all studied indications. From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on Kerendia and more frequently than placebo were hyperkalaemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), hyponatraemia (1.9% vs 0.9%), and events related to worsening renal function (18% vs 12%).
Detailed results from the Phase III FINEARTS-HF trial were published in the New England Journal of Medicine.
“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40% – a large and growing group of patients with a poor prognosis,” said Scott D Solomon (Harvard Medical School and Mass General Brigham, Boston, USA), chair of the executive committee for the FINEARTS-HF study. “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”
“People with heart failure with left ventricular ejection fraction ≥40% face the very real possibilities of hospitalisation for heart failure or cardiovascular death due to their disease,” said Alanna Morris-Simon, senior medical director of US medical affairs at Bayer. “Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalisation for heart failure or cardiovascular death, and 25% who experience hospitalisation are readmitted due to heart failure within one year of discharge. Now, as a core pillar of treatment, Kerendia can help patients reduce these risks.”
Since July 2021, Kerendia has been approved to reduce the risk of cardiovascular death, hospitalisation for HF, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes.
