Bayer announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for KERENDIA® (finerenone) for the treatment of patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of 40%. The submission is based on positive results from the Phase III FINEARTS-HF trial that showed finerenone achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as either an unplanned hospitalization for HF or an urgent HF visit, by 16% in patients with HF and a LVEF of =40% compared to placebo in addition to a patients? prescribed treatment regimen.

Serious adverse events were comparable between treatment groups, occurring in 38.7% (1,157/2,993) of the finerenone group and 40.5% (1,213/2,993) of the placebo group. KERENDIA is the first non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) to meet a primary cardiovascular endpoint in a Phase III study investigating patients with HF with mildly reduced or preserved ejection fraction (LVEF =40%). KERENDIA already has established cardiovascular benefit (reduction in hospitalization for HF, CV death and non-fatal MI) in adults with chronic kidney disease (CKD) in type 2 diabetes (T2D); the data from the FINEARTS-HF trial provide positive results in a different patient population not limited to CKD in T2D?

patients diagnosed with HF (LVEF =40%). HF is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood. Approximately 6.7 million adults in the U.S. live with HF, of which about 55% have a LVEF =40%.

Despite the high prevalence, there are limited guideline-directed medical treatment options for patients with HF with LVEF =40%. This patient group is often balancing multiple comorbidities, such as obesity, diabetes, hypertension and CKD.