Lilly(US:LLY) Prnewswireยท2025-07-09 10:45Core Viewpoint - The FDA has approved a label update for Kisunla (donanemab-azbt), introducing a new dosing schedule that significantly reduces the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) while maintaining its efficacy in amyloid plaque removal and P-tau217 reduction [1][2][3]. Group 1: Dosing Schedule and Efficacy - The modified titration schedule resulted in a 41% reduction in ARIA-E incidence at 24 weeks and a 35% reduction at 52 weeks compared to the original dosing regimen [2][4]. - The new dosing regimen involves a gradual titration, shifting a single vial from the first dose to the third dose, achieving the same total dosage by week 24 [2][3]. - Amyloid plaque levels were reduced by an average of 67% from baseline in the modified titration group, compared to 69% in the original dosing group at the primary endpoint of 24 weeks [4]. Group 2: Clinical Study Insights - The TRAILBLAZER-ALZ 6 study enrolled 843 participants aged 60-85 and focused on the effects of different dosing regimens on ARIA-E [7]. - The primary endpoint was the proportion of participants with any occurrence of ARIA-E by week 24, showing a 14% incidence in the modified titration group versus 24% in the original group [4]. - No new adverse reactions were identified in the study, although higher rates of hypersensitivity and infusion-related reactions were noted [4]. Group 3: Company Commitment and Support Services - Eli Lilly emphasizes its commitment to patient safety and the advancement of Alzheimer's treatment through this updated dosing strategy [2][3]. - Lilly Support Services for Kisunla offers assistance to patients, including coverage determination, care coordination, and personalized resources [5].