Bayer recently announced positive results from the Phase III FINEARTS-HF trial. The use of Kerendia (finerenone) resulted in a clinically meaningful reduction in the composite endpoint of cardiovascular (CV) death and hospitalisation or urgent clinic visits for heart failure (HF).
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, the widespread use of generic HF drugs continues to make it difficult for high-priced branded therapies to fully penetrate the market. GlobalData believes that this study could be of high clinical value to cardiologists who are seeking an optimal treatment of choice for HF patients.
Finerenone is a non-steroidal mineralocorticoid receptor antagonist (MRA). FINEARTS-HF is a randomised, double-blind, placebo-controlled, multicentre, event-driven Phase III trial to assess efficacy and safety of finerenone on top of standard therapies in patients with mildly reduced or preserved left ventricular ejection fraction of 40 percent or greater. 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.
HF and kidney disease often co-exist
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 the use of sodium-glucose co-transporter 2 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. Additionally, key opinion leaders interviewed by GlobalData have emphasised that physicians are reluctant to prescribe MRAs as hyperkalemia is a common adverse event.
Kerendia received US Food and Drug Administration (FDA) approval in July 2021 to reduce the risk of sustained estimated glomerular filtration rate 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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