Finerenone meets primary endpoint in phase III FINEARTS-HF cardiovascular outcomes study in patients with heart failure with mildly reduced or preserved ejection fraction
The Phase III study FINEARTS-HF, evaluating the efficacy and safety of finerenone versus placebo when added to usual therapy in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%, has met its primary endpoint
The results showed that finerenone (Kerendia) achieved a statistically significant and clinically meaningful reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. Finerenone was well-tolerated in the FINEARTS-HF study, which is consistent with the well-established safety profile of finerenone.
Heart failure (HF) is a chronic condition characterized by the progressive decline in the heart’s ability to fill with and pump enough blood to supply the body’s needs. It affects over 60 million people worldwide. Approximately half of these patients suffer from HF with a LVEF of greater than 40%. HF with a LVEF greater than r40% is associated with multimorbidity, with as many as 50% of patients having five or more significant comorbidities, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF.
Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist. By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses hallmarks of HF with a LVEF greater than 40%, such as progressive fibrosis.
“We are very excited by the positive results from the FINEARTS-HF study,” said Dr. Christian Rommel, Head of Research and Development at 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.”
Bayer will discuss the data with health authorities regarding submission of marketing authorization application.
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