Bayer Banks on Kerendia’s Potential in Heart Failure Space

Kerendia (finerenone), manufactured by Bayer and approved two summers ago for the treatment of chronic kidney disease (CKD) linked with type 2 diabetes, is not off to the blazing start that would be anticipated for a potential blockbuster.

An amount of 67 million euros ($73 million) was obtained from sales of Kerendia during the second quarter. In order for Bayer to meet its lofty peak sales goal of 3 billion euros ($3.3 billion), the company will need to broaden the indications for the use of its nonsteroidal mineralocorticoid receptor antagonist (MRA).

In order to get there, Bayer is putting a significant focus on treating heart failure. The firm declared that, in addition to the phase 3 study that is now being conducted, it is planning three further studies for the indication.

In the new studies, Bayer’s drug will be tested on about 9,000 additional patients who had decreased, moderately reduced, or maintained ejection fraction.

Roughly 5,200 individuals who have an ejection fraction higher than 40% will take part in the REDEFINE-HF study, which will explore the use of finerenone as a form of monotherapy. On the other hand, patients with an ejection fraction below 40% will amount to 2600.

Finerenone in conjunction with an SGLT2 inhibitor will be compared to the standard of treatment in the open-label CONFIRMATION-HF trial, which will be conducted on around 1,500 individuals who have been hospitalized or newly released with heart failure. This will be done regardless of the patients’ left ventricular ejection fraction.

The new studies are being conducted in addition to the existing FINEARTS-HF research. That study is comparing finerenone to a placebo in addition to the standard of therapy in 6,000 patients who have a modestly decreased or maintained ejection fraction.

Michael Devoy, Chief Medical Officer at Bayer, stated, “We aim to gain a comprehensive understanding of the potential of finerenone for the treatment of heart failure, examining its efficacy and safety across a broad spectrum of patients and clinical settings.”

Two years ago, findings from the FINEARTS-HF research suggested that the addition of Kerendia to the treatment regimen of heart failure patients who were already on an SGLT2 inhibitor was beneficial to both the heart and the kidneys.

In addition to its potential application in the treatment of individuals suffering from heart failure, Kerenda has demonstrated cardioprotective properties in its authorized uses. It was shown to reduce the risk of abrupt cardiac death by 25% compared to the placebo group, and it also reduced the chance of any sort of cardiovascular event by 18%. This information was reported by Bayer in a prespecified aggregated analysis of two trials that involved individuals with CKD and type 2 diabetes.

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