By Fineline Cube 
Bayer AG (ETR: BAYN) has announced market filings with the US Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its drug finerenone. The German pharmaceutical giant is seeking approvals in both countries for the mineralocorticoid receptor (MR) antagonist to treat adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%, including those with mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).
Finerenone: A First-in-Class Drug
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with this common form of HF. The drug has already been registered in over 90 countries and regions worldwide, including China, Europe, Japan, and the US, for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
Clinical Trial Support
The filings are supported by positive results from the FINEARTS-HF study, which is part of one of the largest Phase III clinical trial programs to date in HF, involving more than 15,000 patients in total. The study was designed to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings. The positive outcomes from the FINEARTS-HF study provide a strong basis for the drug’s potential use in treating HF patients with preserved or mildly reduced LVEF.
Future Prospects
The submission of market filings for finerenone in the US and China represents a significant step forward in expanding the drug’s indications. If approved, finerenone could offer a new treatment option for patients with HF, a condition that affects millions of people globally. Bayer’s efforts to secure approvals in major markets highlight the company’s commitment to improving cardiovascular health and addressing unmet medical needs in the treatment of HF.-Fineline Info & Tech