Kisunla FDA Approval History
Last updated by Judith Stewart, BPharm on July 2, 2024.
FDA Approved: Yes (First approved July 2, 2024)
Brand name: Kisunla
Generic name: donanemab-azbt
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Alzheimer's Disease
Kisunla (donanemab-azbt) is an amyloid beta-directed antibody indicated for the treatment of early symptomatic Alzheimer’s disease.
- Treatment with Kisunla should be initiated in patients in the mild cognitive impairment or mild dementia stage of Alzheimer’s disease, as this was the population in which treatment was initiated in the clinical trials.
- Alzheimer’s disease is an illness that causes progressive decline in memory and other aspects of cognition. It is thought to be caused by the accumulation of amyloid beta peptide in the form of amyloid plaques.
- Kisunla contains donanemab-azbt, a humanized IgG1 antibody that targets a modified form of beta amyloid plaque called N3pG. Kisunla is thought to work by helping the body remove the excessive buildup of amyloid plaques in the brain that may lead to memory and thinking issues associated with Alzheimer's disease.
- FDA approval of Kisunla was based on the results of the TRAILBLAZER-ALZ 2 Phase 3 study, a double-blind, placebo-controlled study designed to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease, with the presence of confirmed amyloid pathology. Participants in the study were divided into two groups: those who were least advanced in their disease (low to medium levels of tau protein) and the overall population (which included participants with high levels of tau protein). Treatment with Kisunla significantly slowed clinical decline in both groups, but the group who were the least advanced in their disease experienced the strongest results with a significant slowing of decline of 35% compared with placebo on the integrated Alzheimer's Disease Rating Scale (iADRS). The overall population experienced a slowing of decline of 22% compared with placebo. Participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease compared to those taking placebo, and a reduction in amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.
- Kisunla is administered as an intravenous infusion over approximately 30 minutes every four weeks.
- The Kisunla product label carries a Boxed Warning for amyloid-related imaging abnormalities (ARIA), which can be detected via magnetic resonance imaging (MRI) scans and may present as temporary swelling or small spots of bleeding in or on the surface of the brain. ARIA can be serious, and life-threatening events can occur. Kisunla can also cause infusion-related reactions which may be serious and life-threatening.
- Common adverse reactions (at least 10% and higher incidence compared to placebo) include ARIA with edema (ARIA-E), ARIA with hemosiderin deposition (ARIA-H) microhemorrhage, ARIA-H superficial siderosis, and headache.
Development timeline for Kisunla
Further information
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