The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Kisunla (donanemab) for the treatment of Alzheimer’s disease.
The FDA granted fast track, priority review, and breakthrough therapy designations to Lilly’s application for Kisunla, which is indicated for patients with mild cognitive impairment or in the mild dementia stage of the disease and administered as an intravenous infusion every four weeks.
Kisunla is the first amyloid plaque-targeting therapy using a limited-duration treatment regimen of amyloid plaque removal, according to a statement from Lilly. In a phase III, double-blind, placebo-controlled study, nearly half of the participants completed their treatment with Kisunla in 12 months; amyloid PET scans showed reduced amyloid plaques by up to 84% after 18 months compared to the start of the study.
The prescribing information for Kisunla includes a boxed warning for amyloid-related imaging abnormalities (ARIA), which usually presents as temporary swelling in areas of the brain. ARIA usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain; while ARIA is usually asymptomatic, serious and life-threatening events may occur rarely, the FDA noted in an announcement.
