On 1 September, at this year’s European Society of Cardiology (ESC) conference, during a late-breaking “Hot Line” session the highly anticipated results of the Phase III FINEARTS-HF trial were presented. The Phase III trial demonstrated the use of Bayer’s Kerendia (finerenone) resulted in a statistically significant reduction in the composite cardiovascular (CV) death and total first and recurrent heart failure (HF) events, defined by either unplanned hospitalisation for HF or urgent clinic visits, by 16% (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007). The study enrolled patients with HF and left ventricular ejection fraction (LVEF) of 40% or greater compared to placebo in addition to a patients’ treatment regimen.
The aging global population will lead to an increase in the prevalence of HF, leading to an expansion of the market as well as a growing need for more therapeutic options. However, the widespread use of generic HF drugs continues to make it difficult for high-priced branded therapies to fully penetrate the market. GlobalData believes this study could be of high clinical value to cardiologists who are seeking an optimal treatment of choice for patients with HF with mildly reduced or preserved ejection fraction.
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Finerenone is a non-steroidal mineralocorticoid receptor antagonist (MRA). Compared to steroidal MRAs, finerenone has a shorter half-life, and has a more balanced distribution between the heart and the kidney. FINEARTS-HF is a randomised, double-blind, placebo-controlled, multicenter, event-driven Phase III trial to assess the efficacy and safety of finerenone for the reduction of risk of CV death and HF events in patients with a diagnosis of symptomatic HF (New York Heart Association class II-IV) with an LVEF of 40% or greater. The findings presented at ESC showed that in patients receiving finerenone, hyperkalemia was more common, and hypokalemia was less common. In addition, findings from the trial were consistent across prespecified subgroups, including LVEF and in those on sodium glucose co-transporter 2 (SGLT2) inhibitors. The large number of patients in the FINEARTS-HF study will likely drive a better understanding of the effects of finerenone in HF across a broad range of patients.
A major trend in the HF treatment landscape is that many companies with approved therapies in other CV diseases are testing them in HF patients for potential label extension. For example, HF and kidney disease often co-exist and exacerbate each other; using a combination of drugs for both indications slows the progressive decline of both organs. A prime example of this strategy is with the use of SGLT2 inhibitors, angiotensin-converting enzyme inhibitors, and MRAs indicated for HF and various types of kidney disease. As Kerendia has only been used in myocardial infarction and kidney disease, cardiologists may be unfamiliar with it and will require guidance on dosage and monitoring instructions for use in HF.
Kerendia received FDA approval in July 2021 to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, CV death, non-fatal myocardial infarction, and hospitalisation for HF in adults with chronic kidney disease associated with type 2 diabetes. Bayer is planning to discuss submission for regulatory approval for HF with the FDA.
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Bayer AG