The FDA has approved Bayer’s finerenone (Kerendia), a non-steroidal mineralocorticoid receptor antagonist (MRA), for patients with heart failure and left ventricular ejection fraction (LVEF) ≥40%. This expands use to those with heart failure with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF).
Previously approved for chronic kidney disease (CKD) and type 2 diabetes (T2D), this latest indication makes finerenone available to heart failure patients without CKD or T2D.
Approval was based on results from Bayer’s Phase III FINEARTS-HF trial, demonstrating improved outcomes in HFmrEF and HFpEF patients.
“Kerendia can now help reduce hospitalization and cardiovascular death risk in a large, underserved heart failure population,” said Alanna Morris-Simon, Bayer’s U.S. medical affairs director.
Scott Solomon, MD, Harvard Medical School, described finerenone as a “new pillar of comprehensive care” following the study’s positive results.
Bayer’s ongoing MOONRAKER program will further evaluate finerenone’s impact in over 15,000 heart failure patients worldwide.
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