Lilly Announces Groundbreaking Kisunla™ (donanemab-azbt) Injection for Early Symptomatic Alzheimer's Treatment
The U.S. Food and Drug Administration (FDA) has approved Kisunla™ (donanemab-azbt), a monthly intravenous treatment by Eli Lilly and Company for adults with early-stage Alzheimer’s disease, including mild cognitive impairment (MCI) and mild dementia, confirmed by amyloid pathology.
Kisunla is the first amyloid plaque-targeting therapy that allows treatment to be discontinued once amyloid plaques are removed, potentially lowering treatment costs and reducing the number of infusions.
Amyloid is a protein that can accumulate in the brain, leading to cognitive issues such as memory loss, planning difficulties, and impaired daily functioning, which are typical in Alzheimer’s disease.
It helps the body eliminate amyloid plaques and slows the decline of cognitive and functional abilities. The treatment was evaluated in the TRAILBLAZER-ALZ 2 Phase 3 study, which found that individuals in the early stages of Alzheimer’s experienced the most significant benefits.
Kisunla also demonstrated a reduction in amyloid plaques, with average reductions of 61% at 6 months, 80% at 12 months, and 84% at 18 months. When participants reached minimal plaque levels, confirmed through amyloid PET scans, they could stop treatment and switch to placebo.
However, Kisunla may cause amyloid-related imaging abnormalities (ARIA), detected through MRI scans, which could lead to temporary brain swelling or bleeding. Serious allergic reactions and headaches are also potential side effects.
The duration of treatment can range from 6 to 18 months. The cost will depend on how quickly patients reach the treatment goal. Patients on Medicare are eligible for coverage.
Kisunla is administered every four weeks and can lead to side effects, including ARIA and infusion-related reactions. Healthcare providers must monitor patients through MRI scans to manage potential risks.
