Tuesday, the FDA said it would convene an in-person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee on Monday, June 10, 2024, to discuss Eli Lilly and Co’s LLY donanemab for early symptomatic Alzheimer’s disease.
The open public hearing portion of the meeting will be conducted virtually.
The Phase 3 study submitted as part of this application, TRAILBLAZER-ALZ 2, is a double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants ages 60-85 years with early symptomatic Alzheimer’s disease.
In March, the agency said that it wants to understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study, including its limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels.
Last year in March, Eli Lilly released the results of the TRAILBLAZER-ALZ 2 Phase 3 study of donanemab for Alzheimer’s disease.
Donanemab treatment slowed clinical decline by 35% compared to placebo and resulted in 40% less decline on the ability to perform activities of daily living.
Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ-3, studying donanemab for the prevention of Alzheimer’s disease.
Price Action: LLY shares are up 0.88% at $773.40 at last check Tuesday.
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