FDA Grants Priority Review to Kerendia in Heart Failure

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

The FDA has granted priority review of the application, which means regulators will review within 6 months of submission, compared with 10 months under standard review. This would result in a PDUFA date and a potential approval of Kerendia in the third quarter of 2025.

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.

“Currently, there are limited treatment options with proven efficacy available to physicians,” Christine Roth, executive vice president, Global Product Strategy and Commercialization and member of the Pharmaceuticals Leadership Team at Bayer, said in a news release.

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.

By targeting the mineralocorticoid receptor (MR) pathway, Karendia addresses key aspects of heart failure, including how blood flows, as well as inflammatory and fibrotic processes. Heart failure is related to the overactivation of the mineralocorticoid receptor, and this can lead to fluid retention and weak functioning.

The submission in heart failure with a left ventricular ejection fraction is based on positive results from the phase 3 FINEARTS-HF trial in which about 6,000 patients were randomized to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

The trial 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 heart failure events compared with placebo.

Serious adverse events were comparable between 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 (high potassium levels) 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.