Bayer AG (FRA: BAYN) announced that it has made another market filing with the European Medicines Agency (EMA) for its drug Kerendia (finerenone), a mineralocorticoid receptor (MR) antagonist. The German pharmaceutical giant is seeking approval in the EU for the drug to treat adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, including both mildly reduced LVEF (HFmrEF) and preserved LVEF (HFpEF).
Global Registration and Clinical Trial Results
Finerenone, the first drug targeting the MR pathway, is already registered in more than 90 countries and regions worldwide, including China, Europe, Japan, and the US, for adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The filing with the EMA leveraged positive results from the FINEARTS-HF study, a Phase III trial that demonstrated the effect of finerenone in preventing the risk of cardiovascular death and heart failure events in patients with LVEF ≥ 40%. Previously, these findings supported marketing filings for the drug with the same indication in the US and China simultaneously.
Future Outlook
With this latest filing, Bayer continues to expand the potential use of Kerendia in addressing heart failure, a significant unmet medical need. The drug’s demonstrated efficacy in preventing cardiovascular events positions it well for further market adoption, reinforcing Bayer’s commitment to improving outcomes for patients with heart failure.-Fineline Info & Tech
