Bayer launches new trials for Kerendia, a potential blockbuster for heart failure

Kerendia, Bayer, chronic kidney disease linked to type 2 diabetes, heart failure,

Two summers ago, Bayer introduced Kerendia (finerenone) as a treatment for chronic kidney disease (CKD) linked to type 2 diabetes. With great expectations of blockbuster status, it’s fair to say that Kerendia’s journey hasn’t been as meteoric as anticipated.

In the recent second quarter, Kerendia’s sales amounted to 67 million euros ($73 million). However, to reach Bayer’s ambitious peak sales target of 3 billion euros ($3.3 billion), a label expansion is essential for this angiotensin-receptor neprilysin inhibitor (ARNI).

To make that leap, Bayer is placing a significant bet on heart failure. Just announced, the company is gearing up for three new phase 3 trials in this domain, in addition to one already in progress.

These forthcoming studies will involve the evaluation of Bayer’s medicine in approximately 9,000 fresh heart failure patients, spanning those with reduced, mildly reduced, and preserved ejection fraction.

“With the addition of the REDEFINE-HF, CONFIRMATION-HF and FINALITY-HF studies to the MOONRAKER heart failure clinical trial program, 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. The studies will complement our Phase III FINEARTS-HF study, and we hope the findings will provide additional guidance around the potential clinical implementation of finerenone.”

– Dr. Michael Devoy, Chief Medical Officer, Bayer

First up is the REDEFINE-HF trial, which will delve into finerenone as a standalone therapy for around 5,200 patients boasting an ejection fraction exceeding 40%. Next, the FINALITY-HF trial will assess finerenone as a monotherapy in roughly 2,600 patients with an ejection fraction below 40%.

Adding to the mix is the open-label CONFIRMATION-HF trial, focused on studying finerenone in conjunction with an SGLT2 inhibitor versus standard of care. This trial will encompass roughly 1,500 patients who have been hospitalized or recently discharged with heart failure, regardless of their left ventricle ejection fraction.

These new trials complement the ongoing FINEARTS-HF study, currently assessing finerenone versus placebo alongside standard care in 6,000 patients with mildly reduced or preserved ejection fraction.

Notably, two years ago, data from the FINEARTS-HF study indicated that Kerendia yielded both heart and kidney benefits when administered to heart failure patients who were already receiving an SGLT2 inhibitor.

Beyond its potential in heart failure treatment, Kerendia has demonstrated cardiovascular benefits in its approved usage. In the past year, Bayer presented a prespecified pooled analysis of two studies involving CKD and type 2 diabetes patients. This analysis revealed that Kerendia reduced the risk of sudden cardiac death by 25% compared to a placebo and cut the risk of various cardiovascular events by 18%. These findings underscore the multifaceted potential of this medication in improving patient outcomes.

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