FDA accepts Bayer’s sNDA for Kerendia for priority review

The US Food and Drug Administration (FDA) accepted and granted Priority Review designation for Bayer’s (BAYN: DE) supplemental new drug application (sNDA) for a new indication for Kerendia (finerenone) in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, ie, mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).

“Kerendia is already an established pillar of therapy to improve cardiovascular outcomes for patients with type 2 diabetes and chronic kidney disease, and Bayer is committed to investigating Kerendia’s benefits in other patient populations, including heart failure,” said Dr Alanna Morris-Simon, senior medical director of US medical affairs, Bayer, adding: “If approved for patients with heart failure with a left ventricular ejection fraction of ≥40%, Kerendia will be an important new treatment option with the potential to become a pillar of therapy to provide cardiovascular benefits in another patient population with unmet need.”

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