Bayer has shared detailed results from a late-stage study evaluating the use of Kerendia (finerenone) in heart failure (HF) patients with mildly reduced or preserved ejection fraction.
The phase 3 FINEARTS-HF 6,000-patient trial has been comparing the non-steroidal mineralocorticoid receptor antagonist to placebo, both taken alongside patients’ prescribed treatment regimens, in those with a diagnosis of symptomatic HF with a left ventricular ejection fraction (LVEF) of at least 40% for up to 42 months.
Data presented at this year’s European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine showed that Kerendia reduced the risk of the composite primary endpoint of cardiovascular death and total HF events, defined as unplanned hospitalisations for HF or urgent HF visits, by 16% compared to placebo.
The results shown in the primary endpoint results were consistent across all pre-specified subgroups and no new safety signals were identified compared with those seen in previous studies of the drug, according to Bayer.
Approximately 55% of the 6.7 million adults in the US with HF have an LVEF of at least 40%, and despite the high prevalence, guideline-directed medical treatment options for this population are limited.
These patients are also usually affected by multiple co-morbidities, including obesity, hypertension and chronic kidney disease (CKD), adding additional considerations for healthcare professionals when considering treatment.
Christian Rommel, head of research and development at Bayer’s pharmaceuticals division, said the results “[underpin the company’s] ongoing commitment to patients with this devastating condition”.
“Based on FINEARTS-HF, Kerendia has shown to reduce the risk of cardiovascular outcomes in a complex-to-treat patient population,” Rommel said.
Kerendia already holds approvals to reduce the risk of cardiovascular 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.
Bayer said it is now planning to discuss the new data and submission for regulatory approval with the US Food and Drug Administration.
The results come just days after Bayer and NextRNA Therapeutics announced a collaboration and license agreement worth $547m to develop small molecule therapeutics against a new class of targets in oncology.