Posted by Michael Wonder on 09 Jul 2025
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease
9 July 2025 - The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding to the established safety profile of the treatment.
Eli Lilly announced today that the US FDA has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Lilly's once monthly amyloid targeting therapy for adults with early symptomatic Alzheimer's disease, which includes people with mild cognitive impairment as well as people in the mild dementia stage of Alzheimer's disease, with confirmed amyloid pathology.
