Eli Lilly’s Kisunla (donanemab-azbt) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of early symptomatic Alzheimer’s disease. This includes adults with mild cognitive impairment (MCI) and mild dementia stages of the disease. Alzheimer’s disease affects women disproportionately, with nearly two-thirds of Americans diagnosed being women.
The pivotal Phase 3 study, TRAILBLAZER-ALZ 2, showed that Kisunla slowed cognitive and functional decline by up to 35% compared to a placebo over 18 months. Participants also experienced up to a 39% reduced risk of progressing to the next clinical stage of Alzheimer’s disease. Anne White, executive vice president of Lilly Neuroscience, stated: “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options.”
Kisunla helps reduce amyloid plaques, a primary characteristic of Alzheimer’s disease that can lead to memory and cognitive issues. This reduction is critical for maintaining patients’ ability to perform daily activities such as remembering information, planning, and organizing.
In the TRAILBLAZER-ALZ 2 study, participants in the early stages of Alzheimer’s showed the most significant benefits. Those with low to medium levels of tau protein experienced a 35% reduction in clinical decline compared to placebo, while the overall population showed a 22% improvement. Kisunla also achieved reductions in amyloid plaques, with a decrease of 61% at 6 months, 80% at 12 months, and 84% at 18 months.
Kisunla’s treatment regimen allows for the possibility of stopping therapy once amyloid plaques are sufficiently reduced, which can lower treatment costs and infusion frequency. In the study, 17% of participants completed treatment at 6 months, 47% at 12 months, and 69% at 18 months.
