By Don Tracy, Associate Editor

The FINEARTS-HF study, which compared Kerendia to a placebo when added to standard therapy, met its primary endpoint by reducing cardiovascular death and total heart failure events.
Results from the Phase III FINEARTS-HF study found that Bayer’s Kerendia (finerenone) demonstrated significant efficacy in treating heart failure patients with a left ventricular ejection fraction (LVEF) of 40% or greater. According to the company, the study met its primary endpoint by significantly reducing the composite measure of cardiovascular death and total heart failure events, including both hospitalizations and urgent visits for heart failure.1
“We are very excited by the positive results from the FINEARTS-HF study,” said Christian Rommel, PhD, head of Research and Development, Bayer’s Pharmaceuticals Division. “With limited options currently available for patients with this common form of heart failure with a mildly reduced or preserved ejection fraction, this news is hugely important for patients and the clinical community. We are looking forward to sharing the data at ESC Congress 2024 and are eager to bring finerenone to eligible patients as soon as possible.”
The randomized, double-blind, placebo-controlled, multicenter, event-driven FINEARTS-HF study investigated the efficacy and safety of Kerendia for the prevention of cardiovascular death and heart failure events in patients with a diagnosis of symptomatic heart failure with a left LVEF of ≥40%, measured by any modality within the past 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. During the trial, approximately 6,000 patients were randomly assigned to receive either Kerendia or placebo once daily for up to 42 months. The study is a part of the larger MOONRAKER clinical trial program.
Kerendia is classified as a non-steroidal, selective mineralocorticoid receptor, targeting renin-angiotensin-aldosterone system overactivation. As a result, it addresses heart failure with a LVEF ≥40%, such as progressive fibrosis.
Heart failure involves a progressive decline in the heart’s ability to fill with and pump enough blood to supply the body’s needs. Currently, it affects over 60 million people globally, with half of these patients facing a LVEF of ≥40%. Further, it is possible that 50% of patients could have 50% or more significant comorbidities, making the condition complex to manage. Bayer stated that these trends suggest that this will soon account for the majority of patients hospitalized with heart failure.1
In the United States, it is currently estimated that around 6.5 million people over the age of 20 years have heart failure, with an estimated 960,000 new cases being diagnosed on a yearly basis. According to the Heart Failure Society of America, heart failure accounts for around 8.5% of all heart disease deaths in the United States and possibly 36% of all cardiovascular related deaths.2
“Life expectancy for a patient depends on many factors and there is no one answer for an individual patient,” reports the Heart Failure Society of America. “When you look at large groups of patients with heart failure, overall, 50% of patients will have an average life expectancy of 5 years. Patients that have less severe heart failure, are well treated with medications, have good renal function, normal blood sugar, and live a healthy lifestyle, can have much better life expectancy than the average heart failure patient. Patients with more severe or advanced heart failure and non-cardiac conditions such as poorly controlled diabetes mellitus and poor kidney function have a much lower life expectancy. For patients with severe or advanced heart failure only around 10% to 20% of patients will be alive after one year.”
Bayer plans to present the data at the upcoming ESC Congress 2024 and intends to seek marketing authorization to make Kerendia accessible to eligible patients.1