FDA Approves Kisunla: A New Hope In Early Alzheimer’s Treatment
April 18, 2025 — Phoenix, AZ — In a significant advancement for Alzheimer’s disease treatment, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Kisunla™ (donanemab-azbt) on July 2, 2024.
This monoclonal antibody therapy is designed for adults with early symptomatic Alzheimer’s disease, encompassing individuals with mild cognitive impairment and mild dementia stages, confirmed by amyloid pathology.
Clinical Efficacy And Unique Treatment Approach
Kisunla targets amyloid beta plaques in the brain, a hallmark of Alzheimer’s pathology. In the pivotal Phase 3 TRAILBLAZER-ALZ 2 study, Kisunla demonstrated a 35% slowing in cognitive and functional decline over 18 months compared to placebo.
Additionally, it reduced the risk of progression to the next clinical stage of the disease by up to 39%.
Notably, Kisunla is the first amyloid plaque-targeting therapy with evidence supporting the cessation of treatment upon the removal of amyloid plaques. This approach may lead to reduced treatment costs and fewer infusions for patients.
Kisunla Administration And Monitoring
Administered as a once-monthly intravenous infusion at a dosage of 350 mg/20 mL, Kisunla requires careful patient selection and monitoring.
Patients undergo regular MRI scans to detect amyloid-related imaging abnormalities (ARIA), such as brain swelling or bleeding.
Which are known risks associated with amyloid-targeting therapies. In clinical trials, ARIA occurred in approximately 36.8% of patients receiving donanemab, compared to 14.9% in the placebo group.
Market Impact And Accessibility
Priced at approximately $32,000 annually, Kisunla enters a competitive market alongside other amyloid-targeting therapies like Leqembi.
Analysts project that Kisunla could generate over $5 billion in annual sales, reflecting the high demand for effective Alzheimer’s treatments.
Medicare is expected to cover Kisunla for eligible patients, although the treatment’s cost and the need for specialized monitoring may pose accessibility challenges.
Efforts are underway to expand diagnostic and treatment infrastructure to accommodate the anticipated demand.
Global Regulatory Landscape
While Kisunla has gained approval in the United States and China, its reception in Europe has been more cautious.
The European Medicines Agency (EMA) declined approval due to concerns over serious side effects, including brain swelling and bleeding.
Eli Lilly is engaging with European regulators to address these concerns and explore potential pathways for approval.
Conclusion
The FDA’s approval of Kisunla marks a pivotal moment in Alzheimer’s disease treatment, offering a new therapeutic option for patients in the early stages of the disease.
With its unique approach allowing for treatment cessation upon plaque removal, Kisunla represents a significant step forward in personalized Alzheimer’s care.
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