Is donanemab (donanemab-azbt)-Kisunla on the market?

Donanemab-azbt, sold under the trade nameKisunla, is a monoclonal antibody used to treat Alzheimer's disease (AD). The U.S. Food and Drug Administration (FDA) approved Kisunla for medical use in the United States in July 2024. The treatment is intended for use in patients with mild cognitive impairment or mild dementia stages of the disease, which is the same population studied to treat in clinical trials. Therefore Kisunla is not yet available globally.

The FDA's approval of Kisunla is based on results from the trail blazer-ALZ Phase 2 and 3 studies, a double-blind, placebo-controlled study designed to evaluate the safety and efficacy of donelumab in participants with early symptomatic Alzheimer's disease and confirmed presence of amyloidosis. Participants in the study were divided into two groups: those with the slowest disease progression (low to moderate levels of tau) and the overall population (which included participants with high tau levels).

Treatment withKisunla significantly slowed clinical decline in both groups, but the group with the slowest disease progression experienced the strongest results on the Integrated Alzheimer's Disease Rating Scale (iADRS), with a significant slowing of decline by 35% compared to placebo. Overall population decline was slowed by 22% compared to placebo. Participants who received Kisunla had a 39% lower risk of progressing to the next clinical stage of the disease compared with those who took placebo, with amyloid plaques reduced by an average of 61% at six months, an average of 80% at 12 months, and an average of 84% at 18 months compared with the start of the study.