Lilly's Kisunla (donanemab-azbt) showed growing benefit over three years in early symptomatic Alzheimer's disease

Core Insights - The TRAILBLAZER-ALZ 2 long-term extension study shows that Kisunla (donanemab-azbt) continues to demonstrate a slowing of cognitive decline over three years, with early treatment significantly reducing disease progression risk [1][2] Study Findings - Participants treated with Kisunla exhibited a cognitive decline reduction of -0.6 at 18 months and -1.2 at 36 months on the Clinical Dementia Rating Sum of Boxes (CDR-SB) compared to an untreated cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI) [5] - Early initiation of Kisunla reduced the risk of progression to the next stage of Alzheimer's disease by 27% on the Clinical Dementia Rating-Global Score (CDR-G) compared to those who started treatment later [5] - Over 75% of participants treated with Kisunla achieved amyloid clearance within 76 weeks [5] - Amyloid plaque reaccumulation remained slow at approximately 2.4 CL/year after up to 2.5 years of observed data in participants who completed treatment [5] - No new safety signals were observed during the three-year LTE period, reinforcing Kisunla's established safety profile [5] Safety Profile - Kisunla is associated with amyloid-related imaging abnormalities (ARIA), which can be serious or life-threatening, although most cases do not present symptoms [4][9] - Common side effects include headache and potential allergic reactions, which may occur during or shortly after infusion [4][13][15] Ongoing Research - Eli Lilly is conducting multiple clinical trials, including TRAILBLAZER-ALZ 3, which evaluates Kisunla's efficacy in preclinical Alzheimer's disease, and TRAILBLAZER-ALZ 5, a registration trial currently enrolling in various countries [7]