Eli Lilly granted FDA label update for Alzheimer’s drug Kisunla

Eli Lilly (NYSE:LLY) announced on Wednesday that the U.S. Food and Drug Administration (FDA) approved a label update for its Alzheimer’s therapy Kisunla (donanemab-azbt) to allow for a new titration dosing schedule.
The once-monthly antibody therapy, approved by the FDA in July 2024 for adults with early symptomatic Alzheimer’s disease, has been linked to a serious adverse event known as amyloid-related imaging abnormalities with edema/effusion (ARIA-E).
Citing data from its TRAILBLAZER-ALZ 6 Phase 3b trial, LLY said that the newly recommended dosing regimen, which involves a more gradual titration, significantly cuts the ARIA-E incidence by 41% and 35% at 24 and 52 weeks, respectively, compared to the original dosing schedule.
“This update underscores our unwavering commitment to patient safety and the advancement of Alzheimer’s disease treatment by potentially mitigating the risk of ARIA-E,” noted Brandy Matthews, Eli Lilly’s (NYSE:LLY) Vice President of Global & US Medical Affairs for Alzheimer’s disease.

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