Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in a Phase III trial.
Bayer, seeking to expand the approval of Kerendia (finerenone) after an initial approval in kidney disease three years ago, is back with data showing that the mineralocorticoid receptor antagonist reduced the risk of cardiovascular death and heart failure by 16%.
The German pharma announced earlier this month that the Phase III FINEARTS-HF trial hit the primary endpoint, which was a composite of cardiovascular death and total heart failure events compared to placebo.
Kerendia was approved in 2021 for adults with chronic kidney disease associated with type 2 diabetes, but the company is eyeing a much bigger market in improving outcomes for people with heart failure with mildly reduced or preserved ejection fraction.
According to Bayer, the new data show that Kerendia significantly reduced the risk of cardiovascular death and total heart failure events, which are defined as hospitalizations or urgent visits, by 16% over a median duration of 32 months. Kerendia also significantly reduced total heart failure events and improved patient-reported outcomes, satisfying the secondary endpoints.
Bayer said the benefits were consistent across all prespecified subgroups, regardless of background therapy, other conditions or hospitalization status. The results were presented over the weekend at the ESC Congress 2024 and also published in the New England Journal of Medicine.
Bayer has placed Kerendia at the center of a plan to hit $3 billion in peak sales. The therapy has underwhelmed in its initial years on the kidney disease market, with Stefan Oelrich, head of Bayer’s pharmaceuticals unit, saying on an earnings call in May that the heart failure market will allow the company to reach that peak sales target.
The FINEARTS-HF study included about 6,000 patients across 630 sites and 37 countries. Patients were randomized to Kerendia or placebo daily while receiving background therapies to manage symptoms and comorbidities.
Bayer’s larger clinical program for Kernedia in heart failure, called MOONRAKER, features around 15,000 total patients.
“In FINEARTS-HF, finerenone reduced cardiovascular outcomes in a complex to treat patient population,” said Christian Rommel, head of research and development at Bayer’s pharmaceuticals division, in a statement. “This confirms the potential of finerenone, if approved, as a valuable treatment option in heart failure with mildly reduced or preserved ejection fraction irrespective of background therapy and disease state.”
