Bayer’s Kerendia (finerenone) has been approved by the US Food and Drug Administration (FDA) to treat heart failure (HF) patients with left ventricular ejection fraction (LVEF) of at least 40%.
The approval was based on positive results from the late-stage FINEARTS-HF trial, in which Kerendia used alongside standard of care achieved a 16% relative risk reduction of the composite primary endpoint of cardiovascular (CV) death and total HF events compared to placebo on top of standard of care.
The treatment effect was consistent across all pre-specified subgroups, Bayer said, adding that the overall safety profile of the drug was consistent across all studied indications.
Approximately 55% of the 6.7 million adults in the US with HF have an LVEF of at least 40%, also known as mildly reduced ejection fraction and preserved ejection fraction.
These patients are usually affected by multiple co-morbidities, including obesity, hypertension and chronic kidney disease (CKD), adding additional considerations for healthcare professionals when determining treatment.
Alanna Morris-Simon, senior medical director of US medical affairs at Bayer, said: “People with HF with LVEF of at least 40% face the very real possibilities of hospitalisation for HF or CV death due to their disease… Now, as a core pillar of treatment, Kerendia can help patients reduce these risks.”
Kerendia, a non-steroidal mineralocorticoid receptor antagonist, is already approved in the US to reduce the risk of CV death, non-fatal myocardial infarction, hospitalisation for HF, sustained eGFR decline, and end-stage kidney disease in adults with CKD associated with type 2 diabetes.
Commenting on the latest approval for the drug, Chair of the executive committee for FINEARTS-HF, Scott Solomon, said: “The FDA’s approval of [Kerendia] expands treatment options for patients with HF with an LVEF of at least 40% – a large and growing group of patients with a poor prognosis.
“Based on the clinical efficacy we saw in the FINEARTS-HF study, [Kerendia] can become a new pillar of comprehensive care.”