Eli Lilly and Company Announces Positive Results from TRAILBLAZER-ALZ 6 Phase 3b Study
Introduction
A change in the initiation of donanemab dosing, shifting one vial of donanemab from the first infusion to the third infusion, lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen used in the pivotal Phase 3 clinical trial. Reduction of amyloid plaque and P-tau217 on this modified titration was comparable to patients receiving the standard dosing regimen. Lilly intends to submit this data to global regulators for a potential label update for Kisunla (donanemab-azbt) INDIANAPOLIS, Oct. 29, 2024 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) today announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer’s disease (AD). Donanemab is approved under the brand name Kisunla™ in the United States, Japan, Great Britain and other countries. These data were presented at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in Madrid, Spain.
How it will effect me
As an individual, this new dosing regimen for donanemab could potentially offer improved efficacy in treating early symptomatic Alzheimer’s disease. The reduction in ARIA-E and comparable reduction of amyloid plaque on the modified titration suggest a more targeted and effective treatment approach. If global regulators approve this modified dosing regimen, it may become a standard of care for individuals with early symptomatic Alzheimer’s disease, providing hope for improved outcomes and quality of life.
How it will effect the world
The positive results from the TRAILBLAZER-ALZ 6 Phase 3b study could have significant implications for the treatment of Alzheimer’s disease on a global scale. A more targeted and effective dosing regimen for donanemab could lead to better outcomes for individuals with early symptomatic AD worldwide. Additionally, if this modified titration is approved and adopted by global regulators, it could set a new standard of care for treating Alzheimer’s disease, potentially changing the landscape of AD treatment and offering hope to millions of individuals affected by this devastating condition.
Conclusion
Overall, the findings from the TRAILBLAZER-ALZ 6 Phase 3b study present promising results for the treatment of early symptomatic Alzheimer’s disease. The slightly modified dosing regimen for donanemab has demonstrated a reduction in ARIA-E and comparable reduction of amyloid plaque, indicating a more effective and targeted approach to treating AD. Pending regulatory approval, this new dosing regimen could have a significant impact on both individual patients and the global healthcare community, offering hope for improved outcomes in the fight against Alzheimer’s disease.
