1. FDA approved Kisunla's new titration dosing for Alzheimer's treatment. 2. New schedule reduces ARIA-E incidence by 41% at 24 weeks. 3. Similar amyloid plaque removal achieved with new dosing regimen. 4. Lilly's commitment to patient safety emphasized with updated regimen. 5. No new adverse reactions observed; hypersensitivity reactions noted.
The FDA's approval and reduced side effects will likely boost Kisunla's adoption and revenues.
This development enhances Kisunla's profile, directly impacting Lilly's stock performance.
As market acceptance grows due to improved safety, long-term sales potential increases.
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.
INDIANAPOLIS, July 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (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 (AD), which includes people with mild cognitive impairment (MCI) 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 (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction.
"We are confident that this label update for Kisunla will significantly aid healthcare professionals in evaluating appropriate treatment options for their patients," stated Brandy Matthews, MD, FAAN, Lilly's Vice President of Global & US Medical Affairs for Alzheimer's Disease. "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."
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.
"This updated dosing strategy is a meaningful advancement for patients and their care teams," said Elly Lee, MD, Chief Medical Officer and Principal Investigator, Irvine Center for Clinical Research. "By significantly reducing the risk of ARIA-E, we can offer patients and care teams greater confidence in the safety of Kisunla while preserving its ability to reduce amyloid."
The U.S. FDA approved Kisunla in July 2024 based on the TRAILBLAZER-ALZ 2 Phase 3 clinical trial data. The study demonstrated that Kisunla significantly slowed cognitive and functional decline in patients who were less pathologically advanced in their disease by up to 35% and by 22% in the overall study population compared to placebo at 18 months. Kisunla reduced the risk of progressing to the next clinical stage of disease by 37% over the same period. Cognitive and functional decline was characterized by more severe memory and thinking problems, more trouble with daily activities, and a greater need for help from caregivers.
Lilly Support Services for Kisunla is dedicated to assisting patients throughout their treatment journey with Kisunla. This free program provides essential services, including coverage determination assistance, care coordination, nurse navigator support, and personalized resources. For more information about Lilly Support Services and Kisunla, visit www.kisunla.lilly.com or call 1-800-LillyRx (1-800-545-5979).
Kisunla™ (donanemab-azbt) (pronounced kih-SUHN-lah) is an amyloid-targeting therapy for people with mild cognitive impairment (MCI) as well as people in mild dementia stage of early symptomatic Alzheimer's disease, with confirmed amyloid pathology. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA, and infusion-related reactions.
The TRAILBLAZER-ALZ studies are Phase 3 investigations designed to evaluate the safety and efficacy of Kisunla (donanemab) in participants with early symptomatic Alzheimer's disease. These studies aim to understand the dosing regimens and their effects on treatment outcomes.
For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or visit kisunla.lilly.com.
This summary provides basic information about Kisunla. It does not include all information known about this medicine. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you.
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