FDA approves Bayer's finerenone to treat wide range of heart failure patients
The U.S. Food and Drug Administration (FDA) has approved finerenone, Bayer’s non-steroidal mineralocorticoid receptor antagonist (MRA) sold under the brand name Kerendia, to treat patients with heart failure who present with a left ventricular ejection fraction (LVEF) of 40% or more.
This covers patients with heart failure with mildly reduced ejection fraction (HFmrEF) or heart failure with preserved ejection fraction (HFpEF).
Finerenone is already approved by the FDA to reduce heart and kidney risks in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This latest approval significantly expands patient access to the drug by making it available to patients without CKD or T2D.
The FDA based its decision on data from FINEARTS-HF, a Bayer-sponsored Phase III clinical trial that linked treatment with finerenone to improved outcomes in patients with HFmrEF or HFpEF.
“Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or cardiovascular death, and 25% who experience hospitalization are readmitted due to heart failure within one year of discharge,” Alanna Morris-Simon, MD, MSc, Bayer’s senior medical director of U.S. medical affairs, said in a statement. “Now, as a core pillar of treatment, Kerendia can help patients reduce these risks.”
“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a LVEF of ≥40%—a large and growing group of patients with a poor prognosis,” added Scott D. Solomon, MD, director of the Clinical Trials Outcomes Center at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School and chair of the FINEARTS-HF executive committee. “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”
FINEARTS-HF is part of Bayer’s ongoing MOONRAKER clinical trial program, which is designed to track the use of finerenone in more than 15,000 heart failure patients around the world. A separate program focused on CKD data—titled THUNDERBALL to continue the James Bond theme—is also underway.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.