Bayer's Kerendia achieves primary goal in heart failure study

Bayer announced that its drug Kerendia (finerenone) achieved the primary endpoint in a Phase III clinical trial for patients with heart failure (HF) who have a mildly reduced or preserved left ventricular ejection fraction (LVEF). The drug significantly reduced the risk of cardiovascular (CV) mortality and HF events compared to placebo. Christian Rommel, head of R&D at Bayer’s pharmaceutical division, emphasized the importance of this development, noting the limited treatment options available for this common form of heart failure. The company intends to discuss with regulatory authorities the possibility of expanding the drug's label. Kerendia is already approved in the US and Europe for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes and is marketed under the name Firialta in some countries.

The FINEARTS-HF study enrolled 6016 patients with HF and an LVEF of at least 40%. Participants were randomly assigned to receive either Kerendia or a placebo once daily in addition to their usual therapy, for up to 42 months. The top-line results indicated that Kerendia significantly reduced the composite endpoint of CV death and total HF events, which includes hospitalizations or urgent hospital visits for HF, when compared to the placebo group. The drug was well-tolerated, with a safety profile consistent with previous studies. Detailed findings from the study will be presented at the upcoming European Society of Cardiology (ESC) congress.

Bayer is pursuing an extensive clinical development program for Kerendia, known as FINEOVATE, which encompasses 10 late-stage trials across HF and CKD. The MOONRAKER sub-programme, which focuses on HF, includes the FINEARTS-HF trial along with REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. On the CKD front, the FIDELIO-DKD and FIGARO-DKD studies, part of the THUNDERBALL sub-programme, have already achieved their primary objectives, and additional trials are currently in progress.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!