Core Viewpoint - Bayer AG has submitted a supplemental new drug application (sNDA) to the FDA for Kerendia (finerenone) to treat heart failure with a left ventricular ejection fraction (LVEF) of ≥40% [1][4] Group 1: FDA Approval Process - The FDA has granted a priority review for the sNDA, with a decision expected in the third quarter of 2025, reducing the review period to six months [2] - The sNDA is based on positive data from the phase III FINEARTS-HF study, which evaluated Kerendia's safety and efficacy in patients with symptomatic heart failure [4][5] Group 2: Market Context and Product Information - Finerenone is already marketed as Kerendia in over 90 countries for chronic kidney disease associated with type 2 diabetes [3] - A potential approval for the heart failure indication could expand Bayer's market reach, addressing a broader patient population with limited treatment options [8] Group 3: Clinical Study Insights - The FINEARTS-HF study demonstrated that Kerendia significantly improved cardiovascular outcomes in patients with heart failure and LVEF of ≥40% compared to placebo [5][6] - Finerenone is noted as the first drug targeting the mineralocorticoid receptor pathway to show cardiovascular benefits in a phase III study for this patient group [6]
Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority Review