By Fineline Cube 
German pharmaceutical giant Bayer AG (ETR: BAYN) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its drug Kerendia (finerenone) to treat adult heart failure (HF) patients with ejection fraction ≥40%. This approval marks a significant advancement in the treatment options for this specific patient population.
Kerendia’s Mechanism and Benefits
Kerendia is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) designed to reduce the risk of cardiovascular death, HF hospitalization, and urgent HF visits. Its innovative mechanism of action provides a new therapeutic approach for managing heart failure.
Clinical Trial Support
The FDA’s approval is supported by positive results from the pivotal Phase III FINEARTS-HF trial. The trial demonstrated Kerendia’s significant reduction in cardiovascular mortality and total HF events, including both first and recurrent episodes.
Global Marketing Applications
Bayer has also submitted marketing authorization applications for this indication to China’s National Medical Products Administration (NMPA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).-Fineline Info & Tech