May 2024- The U.S. Food and Drug Administration (FDA) will convene an in-person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on Monday, June 10, 2024, to discuss donanemab, which Eli Lilly and Company has submitted for the treatment of early symptomatic Alzheimer’s disease. The committee will conduct the open public hearing portion of the meeting 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 (mild cognitive impairment or mild dementia due to Alzheimer’s disease) with the presence of confirmed Alzheimer’s disease neuropathology. Alzheimer’s disease is a progressive and fatal disease that in its early symptomatic stages affects 6-7.5 million Americans. The trial enrolled 1,736 participants, across eight countries, selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by positron emission tomography (PET) imaging.
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Furthermore, The Journal of the American Medical Association (JAMA) published the results of the TRAILBLAZER-ALZ 2 study. Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ-3, studying donanemab for the prevention of Alzheimer’s disease.
