Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster.
In the second quarter, sales of Kerendia reached 67 million euros ($73 million). For Bayer to achieve its ambitious peak sales target of 3 billion euros ($3.3 billion), it will have to expand the label of the nonsteroidal mineralocorticoid receptor antagonist (MRA).
To get there, Bayer is making a big play in heart failure. Thursday, the company said it's planning three new phase 3 trials in the indication, in addition to one that's already underway.
The new studies will evaluate Bayer's medicine in roughly 9,000 new heart failure patients with reduced, mildly reduced and preserved ejection fraction.
The REDEFINE-HF trial will investigate finerenone as a monotherapy in approximately 5,200 patients with an ejection fraction of greater than 40%. The FINALITY-HF trial will assess finerenone as a monotherapy in roughly 2,600 patients with an ejection fraction of less than 40%.
The open-label CONFIRMATION-HF trial will study finerenone in combination with an SGLT2 inhibitor versus standard of care in roughly 1,500 patients who have been hospitalized or recently discharged with HF, independent of their left ventricle ejection fraction.
The new trials come on top of the ongoing FINEARTS-HF study, which is assessing finerenone versus placebo plus standard of care in 6,000 patients with mildly reduced or preserved ejection fraction.
“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,” Michael Devoy, Bayer’s chief medical officer, said in a release.
Two years ago, data from the prespecified FIDELITY pooled analysis indicated that Kerendia offered heart and kidney benefits when used in heart failure patients already receiving an SGLT2 inhibitor.
Aside from its potential in treating patients with heart failure, Kerendia has shown cardio benefits in its approved use. Last year, Bayer presented a prespecified pooled analysis of two studies of patients with CKD and type 2 diabetes that showed Kerendia cut the risk of sudden cardiac death by 25% versus placebo and the risk of any type of cardiovascular event by 18%.