Bayer’s Kerendia Demonstrates 16% Reduction in Cardiovascular Risk for Heart Failure Patients

Cardiovascular Risk Reduction:
Bayer's Kerendia (finerenone) reduced the risk of cardiovascular death and heart failure by 16% in a Phase III trial (FINEARTS-HF) involving about 6,000 patients across 630 sites and 37 countries.

Approval and Expansion:
Initially approved in 2021 for adults with chronic kidney disease associated with type 2 diabetes, Bayer is seeking to expand Kerendia's approval to include heart failure with mildly reduced or preserved ejection fraction.

Clinical Program:
The FINEARTS-HF study is part of Bayer's larger clinical program for Kerendia in heart failure, known as MOONRAKER, which includes around 15,000 total patients.

Peak Sales Forecast:
Bayer aims to reach $3 billion in peak sales with Kerendia, with the heart failure market expected to significantly contribute to this target.

Consistent Benefits:
The benefits of Kerendia were consistent across all prespecified subgroups, regardless of background therapy, other conditions, or hospitalization status.

Publication and Presentation:
The results were presented at the ESC Congress 2024 and published in the New England Journal of Medicine.