Bayer Submits Supplemental NDA for Kerendia in Heart Failure

Bayer has submitted a supplemental new drug application (sNDA) for Kerendia (finerenone) to treat patients with heart failure with a left ventricular ejection fraction (LVEF) of ≥40%.

Ejection fraction is a condition in which the left side of the heart stiffens and cannot pump blood properly. Nearly 7 million people in the United States are affected by heart failure. In 2022, it was responsible for almost 14% of deaths, according to data from Centers for Disease Control and Prevention.

“More than half of the approximately 6.7 million adults in the United States diagnosed with heart failure have an LVEF ≥40%, but there are limited guideline-directed treatment options available for these patients,” Alanna Morris, M.D., MSc, senior medical director of U.S. Medical Affairs, Bayer, said in a news release. “If approved, Kerendia could serve as a new pillar of therapy in this disease and improve cardiovascular outcomes for patients with high unmet medical need.”

Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA). It was approved by the FDA in July 2021 to slow the progression of chronic kidney disease (CKD) associated with type 2 diabetes. In adults with chronic kidney disease associated with type 2 diabetes, Kerendia has been recommended to improve cardiovascular outcomes and reduce the risk of cardiovascular and kidney failure.

Kerendia has a list price of $686.70 per month. Bayer offers a $0 copay card for commercially insured patients.

The submission in heart failure with a left ventricular ejection fraction is based on positive results from the phase 3 FINEARTS-HF trial that showed finerenone achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) heart failure events. The trial met its primary endpoint, achieving a 16% relative risk reduction of the composite primary endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits) compared with placebo in addition to a patients’ prescribed treatment regimen.

Serious adverse events were comparable between treatment groups, occurring in 38.7% of the finerenone group and 40.5% of the placebo group. Discontinuation of the trial drug for reasons other than death was similar between groups, with 20.4% in the finerenone group and 20.6%. in the placebo group. Finerenone was associated with an increased risk of hyperkalemia, or high potassium levels, with investigator-reported hyperkalemia in 9.7% of finerenone-treated patients versus 4.2% in the placebo group.

The results were presented at the 2024 European Society of Cardiology (ESC) Congress and published in The New England Journal of Medicine.