Eli Lilly announces FDA approval of label update for Kisunla

Eli Lilly (LLY) announced that the FDA has approved a label update with a new recommended titration dosing schedule for Kisunla, 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 AD, with confirmed amyloid pathology. In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. The new recommended dosing regimen involves a more gradual titration, and the TRAILBLAZER-ALZ 6 study significantly lowered the incidence of ARIA-E by 41% at 24 weeks and by 35% at 52 weeks versus the original dosing schedule. ARIA-E is a side effect of amyloid plaque-targeting therapies, including Kisunla. ARIA-E is usually asymptomatic, although serious and fatal events can occur. The new dosing recommendation differs from the original dosing by shifting a single vial from the first dose to the third dose, delivering the same amount of Kisunla by week 24. This resulted in lower rates of ARIA-E without compromising Kisunla’s ability to reduce amyloid plaque or Kisunla’s once-monthly dosing with the potential for limited-duration treatment based on amyloid plaque removal to minimal levels.