Bayer touted a win in a Phase 3 heart failure study with Kerendia on Monday, announcing that the drug hit the primary endpoint in the study.
Though the German drugmaker didn’t release any data with the announcement, the company said that in the FINEARTS-HF study, patients saw a statistically significant reduction in cardiovascular death and total heart failure events, defined as hospitalizations or an urgent visit for heart failure. About 6,000 patients were randomized to receive either Kerendia or placebo for up to 42 months.
Bayer plans to discuss the data for a potential approval with the FDA.
The FDA approved Kerendia in 2021 for adults with chronic kidney disease associated with type 2 diabetes to reduce the risk of eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and heart failure hospitalization. A label expansion based on the new trial would open it up to a broader patient population.
According to Bayer, Kerendia is the first non-steroidal, selective mineralocorticoid receptor antagonist to meet a primary cardiovascular endpoint in a late-stage study in patients with heart failure with mildly reduced or preserved ejection fraction. The data will be presented at the European Society of Cardiology Congress in September.
Christian Rommel“Bayer is determined to drive research and innovations that have the potential to become treatment options for diseases with high unmet medical need, including for patients with mildly reduced or preserved ejection fraction,” Christian Rommel, head of R&D for Bayer’s pharmaceuticals division, wrote in a statement.
The trial is just one in the vast MOONRAKER heart failure program with Kerendia, which has more than 15,000 patients across four trials. Last year, Bayer announced that it would expand Kerendia’s heart failure program to include three more studies in patients with reduced ejection infraction (HfrEF), mildly reduced HfmrEF or preserved HfpEF, testing the drug on top of standard of care or a newer drug class.
The company said in its 2023 financial report that it expects 2024 sales of the drug to hit €500 million. It pulled in €270 million in 2023 and €85 million in the first quarter of this year.