FINEARTS-HF trial results in clinically meaningful reduction in the composite endpoint of CV death

Bayer recently announced positive results from the Phase III FINEARTS-HF trial, which showed that the use of Kerendia (finerenone) resulted in a clinically meaningful reduction in the composite endpoint of cardiovascular (CV) death and hospitalisations or urgent clinic visits for heart failure (HF). The study could be of high clinical value to cardiologists who are seeking an optimal treatment of choice for HF patients, which highlights that Bayer’s Kerendia holds the potential to differentiate in HF, says GlobalData.

Finerenone is a non-steroidal mineralocorticoid receptor antagonist (MRA). FINEARTS-HF is a randomised, double-blind, placebo-controlled, multicenter, event-driven Phase III trial to assess the efficacy and safety of finerenone on top of standard therapies in patients with a mildly reduced or preserved left ventricular ejection fraction of 40 per cent or greater.

Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments, “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 for other CV diseases are testing them in HF patients for potential label extension.”

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 the use of sodium-glucose co-transporter 2 inhibitors, angiotensin-converting enzyme inhibitors, and MRAs indicated for HF and various types of kidney disease.

Jaddoo continues, “The ageing 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, widespread use of generic HF drugs continues to make it difficult for high-priced branded therapies to fully penetrate the market.”

Bayer recently announced that it is planning to discuss the submission for regulatory approval of Kerendia for HF with the FDA.

Jaddoo concludes, “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. Key opinion leaders (KOLs) interviewed by GlobalData have emphasised that physicians are reluctant to prescribe MRAs as hyperkalemia is a common adverse event.”

Edits made by EP News Bureau