FDA Approves Lilly's Kisunla? (donanemab-azbt) for Early Symptomatic Alzheimer's Disease Treatment

The U.S. Food and Drug Administration (FDA) has approved Kisunla? (donanemab-azbt), a once-monthly injection (350 mg/20 mL) for IV infusion developed by Eli Lilly and Company (NYSE: LLY). Kisunla is designed to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) and mild dementia stages of AD, with confirmed amyloid pathology. This is the first and only amyloid plaque-targeting therapy that allows stopping treatment when amyloid plaques are cleared, potentially reducing costs and the number of infusions needed.

"Kisunla has shown very meaningful results for people with early symptomatic Alzheimer's disease who urgently need effective treatments," said Anne White, executive vice president and president of Lilly Neuroscience. "We know these medicines work best when administered early in the disease, and we are collaborating to improve early detection and diagnosis. Our thanks go to the patients, their families, and the Lilly scientists and collaborators for their dedication to decades of research. We are committed to improving lives as more people are at risk each year."

Amyloid plaques are clumps of naturally occurring amyloid protein in the brain that can impair memory and cognitive functions, leading to Alzheimer's. Kisunla helps reduce amyloid plaques, potentially slowing the decline in memory, organization, and daily activities.

In the TRAILBLAZER-ALZ 2 Phase 3 study, Kisunla showed the strongest results in people with early stages of the disease. Participants were assessed over 18 months in two groups: those with low to medium tau protein levels and the overall population, which included those with high tau levels. Kisunla significantly slowed clinical decline in both groups. For those less advanced in the disease, Kisunla slowed decline by 35% compared to placebo on the integrated Alzheimer's Disease Rating Scale (iADRS), which evaluates memory, thinking, and daily function. In the overall population, the decline slowed by 22% on the iADRS. Additionally, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage compared to those on placebo.

Overall, Kisunla reduced amyloid plaques by 61% at 6 months, 80% at 12 months, and 84% at 18 months from the start of the study. One study goal was to achieve minimal amyloid plaque levels consistent with a visually negative PET scan. Participants reaching these levels could stop Kisunla and switch to placebo for the remainder of the study.

Kisunla can cause amyloid-related imaging abnormalities (ARIA), detectable via MRI scans, usually presenting as temporary brain swelling or small spots of bleeding, which generally resolve over time. Larger brain bleeding areas are rare but can occur. ARIA can be serious, with potentially life-threatening events. Kisunla may also cause allergic reactions, some serious and life-threatening, typically during or shortly after infusion. Headache is another common side effect. For more safety information, see the Indication and Safety Summary with Warnings.

"This approval represents progress in the standard of care for Alzheimer's, offering hope to patients and caregivers," said Dr. Howard Fillit, Co-Founder and Chief Science Officer at the Alzheimer's Drug Discovery Foundation (ADDF). "Early diagnosis and treatment could significantly slow disease progression, giving patients more time to maintain their independence."

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