Brain edema risk expected to be less with new donanemab dosing schedule

The FDA approved a label updateopens in a new tab or window with a new titration schedule for donanemab (Kisunla), an anti-amyloid drug approved to treat early symptomatic Alzheimer’s disease, drugmaker Eli Lilly saidopens in a new tab or window.

The move was designed to reduce the risk of a potentially serious or fatal adverse event — known as amyloid-related imaging abnormalities with edema and effusion (ARIA-E) — while maintaining sufficient amyloid reduction.

In the TRAILBLAZER-ALZ 6opens in a new tab or window study, the modified titration schedule significantly lowered the incidence of ARIA-E versus the original dosing schedule while still achieving similar levels of amyloid plaque removal.

https://www.medpagetoday.com/neurology/alzheimersdisease/116438

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