FDA Approves Lilly’s Kisunla for Alzheimer’s Disease
On July 2, 2024, the US FDA approved Kisunla (kih-SUHN-lah, donanemab-azbt) for the treatment of Alzheimer’s disease in people with early symptomatic Alzheimer’s disease. A characteristic marker of Alzheimer’s is amyloid plaques. These plaques are caused by an accumulation of naturally occurring amyloid protein and deposits in the brain, affecting cognition, memory, and executive function. Kisunla is a monthly injection that targets amyloid plaques. Kisunla helps the body remove excess amyloid, resulting in an average 61%-84% reduction of plaques, depending on the length of treatment. Alzheimer’s treatments have the greatest potential effects the earlier in the disease timeline they are implemented. Kisunla is approved for people with mild cognitive impairment (MCI) and those with mild Alzheimer’s dementia with a confirmed amyloid pathology. Jacksonville Center for Clinical Research participated in the TRAILBLAZER clinical trials. Eli Lilly and Company says Kisunla should be available to authorized specialty distributors for ordering this month.
Source: https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early