FDA Approves New Dosing Schedule For Eli Lilly's Kisunla In Alzheimer's Treatment

The U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Eli Lilly and Co.’s (NYSE:LLY) Kisunla (donanemab-azbt) once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer’s disease (AD). The FDA approved the drug in July 2024.

In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly reduced the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) compared to the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction.

The new recommended dosing regimen involves a more gradual titration.

ARIA-E is a side effect of amyloid plaque-targeting therapies, including Kisunla. ARIA-E is usually asymptomatic, although serious and fatal events can occur.

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