In a significant move, the U.S. Food and Drug Administration granted approval for Kerendia (finerenone) for patients with heart failure with ≥40% left ventricular ejection fraction (LVEF).
Kerendia, a nonsteroidal mineralocorticoid receptor antagonist that inhibits overactivation of mineralocorticoid receptors in the heart and kidneys.
It particularly targets heart failure with LVEF ≥40%.
FDA’s approval to finerenone was based on the results of a phase 3 trial (FINEARTS-HF), in which Kerendia, including the standard of care, minimised the risk for the composite primary end point, cardiac mortality and total cardiac failure events by 16% to placebo plus standard of care.
Cardiac failure events were defined as urgent visits for heart failure. The efficacy of treatment remained uniform across all prespecified subgroups.
Adverse effects reported in at least 1% participants (and more often as compared to the placebo group) were hypotension, abnormal hyponatremia, hyperkalemia, and kidney failure.
Chair of the Executive Committee for the FINEARTS-HF study from Harvard Medical School and Mass General Brigham in Boston, Scott D. Solomon, M.D., stated:
"The FDA's approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40 percent -- a large and growing group of patients with a poor prognosis."
"Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care," Solomon added.
Notably, Bayer received Kerendia’s approval.
