Bayer’s Kerendia Achieves Primary Endpoint in Phase III Heart Failure Study

Primary Endpoint Achieved::
Bayer's Kerendia (finerenone) has successfully met the primary endpoint in a Phase III cardiovascular outcomes study in patients with heart failure (HF) having mildly reduced or preserved ejection fraction.

Study Details::
The FINEARTS-HF study involved around 6,000 patients with symptomatic heart failure, who were randomized to receive either finerenone or a placebo once a day for up to 42 months.

Positive Outcomes::
The study showed that finerenone significantly reduced the composite of cardiovascular death and total heart failure events compared to the placebo, leading to the trial hitting its primary endpoint.

Regulatory Plans::
Bayer plans to discuss the results with regulatory agencies to seek approval for finerenone in the heart failure indication, which is crucial for achieving peak sales of over $3 billion.

Previous Approval::
Finerenone was previously approved by the FDA in 2021 for adults with chronic kidney disease associated with type 2 diabetes.

Tolerability::
The drug was well tolerated in the study, with a lower risk of elevated potassium levels compared to other mineralocorticoid receptor antagonists.

Market Potential::
Despite a slow start in the kidney disease market, Bayer remains optimistic about the drug's potential in heart failure, which could drive significant sales growth.