ESC24: Bayer's Kerendia Reduces CV Mortality, HF Events by 16%

Bayer recently announced that its drug Kerendia (finerenone) demonstrated a 16% reduction in the risk of cardiovascular (CV) mortality and heart failure (HF) events in patients with mildly reduced or preserved left ventricular ejection fraction (LVEF), compared to a placebo. This was observed across all patient subgroups in a Phase III clinical trial. Christian Rommel, head of research and development at Bayer's pharmaceutical division, emphasized the findings, noting the potential of Kerendia as a treatment option regardless of background therapy and disease conditions.

The detailed findings were presented at the European Society of Cardiology (ESC) Congress. The FINEARTS-HF study, which was previously reported last month, involved 6016 heart failure patients with an LVEF of at least 40%. Participants received either a daily dose of Kerendia or a placebo in addition to their standard treatment.

Results indicated that Kerendia successfully achieved its primary goal, significantly reducing the risk of a composite of CV death and total HF events, which included hospitalizations or urgent hospital visits, by 16% compared to the placebo over a median period of 32 months. This primary benefit was consistent across all subgroups, irrespective of other therapies, comorbidities, hospitalization status, ejection fraction, or use of SGLT2 inhibitors.

Moreover, Kerendia met key secondary goals against the placebo. It reduced total HF events by 18% and improved patient-reported health status, as indicated by a significant 1.6-point difference on the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).

In terms of safety, Bayer reported that Kerendia was well-tolerated and had a safety profile similar to what was already known. The frequency of serious adverse events was comparable between the Kerendia and placebo groups. Although hyperkalaemia-related adverse events were more frequent in the Kerendia group (9.7% compared to 4.2% in the placebo group), there were no fatal cases, and hospitalizations or discontinuations due to hyperkalaemia were rare.

Based on data from the FINEARTS-HF study, Bayer plans to seek a label expansion for Kerendia. The drug is a non-steroidal mineralocorticoid receptor antagonist that has already received approval in the US, Europe, and other countries for treating chronic kidney disease (CKD) in patients with type 2 diabetes. In some regions, it is marketed under the name Firialta.

Additionally, Bayer presented late-breaking data from a pooled analysis of three pivotal Phase III Kerendia studies – FINEARTS-HF, FIDELIO-DKD, and FIGARO-DKD – at the Congress. The pooled analysis showed that Kerendia lowered the incidence of CV death by 11% compared to placebo, although this narrowly missed statistical significance. In a sensitivity analysis that included both CV and undetermined deaths, Kerendia significantly reduced the risk by 12%.

These findings were consistent across 16 subgroups and indicated improvements in overall mortality, as well as CV and renal outcomes. According to Rommel, heart failure, CKD, and type 2 diabetes share common disease mechanisms, and the FINE-HEART analysis complements and confirms the positive results seen so far with Kerendia.

The FINEARTS-HF trial is part of Bayer's MOONRAKER program focusing on heart failure, which also includes the REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF trials. Meanwhile, the THUNDERBALL program for CKD includes the FIDELIO-DKD and FIGARO-DKD trials, among others.

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