Bayer has shared positive results from a late-stage study of Kerendia (finerenone) in heart failure (HF) patients with mildly reduced or preserved ejection fraction.
The non-steroidal mineralocorticoid receptor antagonist 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 chronic kidney disease (CKD) associated with type 2 diabetes.
The phase 3 FINEARTS-HF trial has been evaluating the investigational use of Kerendia in about 6,000 patients with a diagnosis of symptomatic HF with a left ventricular ejection fraction (LVEF) of at least 40% who were randomised to receive either Bayer’s drug or placebo once daily for up to 42 months.
Approximately 55% of the 6.7 million adults in the US with HF have an LVEF of at least 40%. 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 CKD, adding additional considerations for healthcare professionals when considering treatment.
FINEARTS-HF met its primary endpoint, demonstrating a statistically significant reduction of the composite of cardiovascular death and total HF events, defined as hospitalisations for HF or urgent HF visits.
No new safety signals were identified compared with those seen in previous studies of the drug.
Bayer said it will present the data at this year’s European Society of Cardiology Congress in September, adding that it plans to discuss submission for regulatory approval with the US Food and Drug Administration.
Dr Christian Rommel, head of research and development at Bayer’s pharmaceuticals division, said the company is “determined to drive research and innovations that have the potential to become treatment options for diseases with high unmet medical needs, including for patients with mildly reduced or preserved ejection fraction”.
The results come a few weeks after Bayer and Orion’s darolutamide demonstrated significant survival benefits as part of a combination treatment in patients with metastatic hormone-sensitive prostate cancer.
The phase 3 ARANOTE trial met its primary endpoint, with darolutamide plus androgen deprivation therapy (ADT) significantly increasing radiological progression-free survival compared to placebo plus ADT.