FDA Approves Finerenone for HF Patients With Mildly Reduced or Preserved EF

The US Food and Drug Administration has approved the use of finerenone (Kerendia) in heart failure (HF) patients with mildly reduced or preserved ejection fraction, drugmaker Bayer announced Monday.

The agency’s decision is based on the phase III FINEARTS-HF trial showing that the nonsteroidal mineralocorticoid receptor antagonist (MRA) cuts the risk of worsening HF events and cardiovascular mortality for patients with LVEF ≥ 40% when compared with placebo.

Prior to FINEARTS-HF, randomized trials—RALES, EMPHASIS-HF, and TOPCAT—testing the steroidal MRAs spironolactone and eplerenone showed benefit only in HF patients with an ejection fraction < 40%.

In Bayer’s press release, FINEARTS-HF study chair Scott Solomon, MD (Harvard Medical School and Mass General Brigham, Boston, MA), points out that the new approval expands treatment for “a large and growing group of patients with a poor prognosis.” The company says there are approximately 3.7 million adults in the United States who have HF with mildly reduced or preserved ejection.

“Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care,” added Solomon.

In FINEARTS-HF, which was published last September in the New England Journal of Medicine, the 16% relative risk reduction in the primary endpoint of CV death and total HF events was driven mainly by reductions in the HF component. The study found no treatment interaction based on whether patients were taking a sodium-glucose cotransporter 2 inhibitor. While the overall rate of adverse events was similar with finerenone and placebo, the patients receiving the nonsteroidal MRA had a higher risk of hyperkalemia (9.7% vs 4.2%) and were more likely to have elevated creatinine levels (2.0% vs 1.2%).

This new approval follows the FDA’s 2021 sign-off on the use of finerenone for patients with diabetes-associated chronic kidney disease, based on data from the FIGARO-DKD and FIDELIO-DKD trials.