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FDA Approves New Dosing Schedule For Eli Lilly's Kisunla In Alzheimer's Treatment - Eli Lilly (NYSE:LLY)

UNITED STATES, JUL 9 – The FDA-approved gradual dosing reduces amyloid-related imaging abnormalities by up to 41%, enhancing safety for adults with early symptomatic Alzheimer's disease treated with Kisunla.

  • On July 9, 2025, the FDA approved a label update for Eli Lilly's Alzheimer's drug Kisunla, introducing a new dosing schedule in the US.
  • This update followed TRAILBLAZER-ALZ 6 study results showing that deferring one dose in titration reduced the incidence of ARIA-E, a serious brain swelling side effect.
  • The new dosing starts with one 350 mg vial for the first infusion, increases to three vials by the third dose, and four vials for subsequent treatments without reducing amyloid plaque removal.
  • ARIA-E incidence dropped 41% at 24 weeks with modified dosing , and at 52 weeks by 35% , described as a "meaningful advancement" by study investigator Elly Lee.
  • This update aims to improve Kisunla’s safety profile and support treatment confidence amid slow sales and regulatory challenges in Europe, where Lilly plans CHMP re-examination.
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Benzinga broke the news in New York, United States on Wednesday, July 9, 2025.
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