The FDA has approved a label update for Eli Lilly’s Kisunla, an Alzheimer’s treatment, by modifying the recommended dosing schedule for adults with early symptomatic Alzheimer’s disease.
The update introduces a gradual titration schedule aimed at reducing risk of amyloid-related imaging abnormalities with edema, a known side effect of amyloid plaque-targeting therapies, according to a July 9 news release from the drugmaker. In a recent study, patients receiving the modified dosing experienced significantly fewer events, 14% at 24 weeks and 16% at 52 weeks compared to 24% and 25%, respectively, among patients on the original dosing schedule.
Kisunla, approved in 2024, is administered once monthly and designed for limited-duration use depending on plaque removal. The therapy is meant for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
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