FDA Sets Date to Discuss Donanemab at Advisory Committee Meeting

The Food and Drug Administration (FDA) has announced that it will convene an advisory committee meeting on June 10, 2024 to discuss the investigational drug donanemab (Eli Lilly and Company, Indianapolis, IN) for the treatment of Alzheimer disease. The meeting will allow a panel of experts to review the safety and efficacy data from the phase 3 TRAILBLAZER-ALZ 2 (NCT04437511) study, which evaluated donanemab treatment in participants aged 60 to 85 years who were diagnosed with early symptomatic Alzheimer disease. The study enrolled 1736 participants across 8 countries, selecting them based on cognitive assessments, amyloid plaque imaging, and tau staging.

Lilly had expected donanemab to be approved in the first quarter of 2024, but the FDA has delayed its decision to hold the advisory committee meeting. The agency wants to further understand the safety results, particularly regarding amyloid-related imaging abnormalities (ARIA), as well as the efficacy implications of the study's unique trial design that allowed patients to stop treatment after amyloid plaques were cleared.