FDA releases documents ahead of panel review of Eli Lilly’s donanemab

The FDA has released background information prepared by the Food and Drug Administration for the panel members of the Peripheral and Central Nervous System Advisory Committee Meeting that is being convened on June 10 to discuss whether the data from the Phase 3 Study AACI, or TRAILBLAZER-ALZ 2, support a favorable benefit-risk assessment for the use of donanemab for the treatment of Alzheimer’s disease, or AD. Eli Lilly and Company, the applicant, originally submitted an application for accelerated approval of donanemab based on amyloid plaque reduction in phase 2 Study AACG. That application received a complete response letter on January 18, 2023, because the safety database was insufficient to adequately characterize the long-term safety of donanemab for the treatment of AD, the FDA noted. The current application for traditional approval includes the results of the pivotal clinical study and is intended to address the deficiencies outlined in the CR letter. The FDA staff stated in the documents: “In summary, the main safety signals associated with the use of donanemab are ARIA, cerebral hemorrhage, and infusion-related reactions and hypersensitivity. The safety findings are generally consistent with findings associated with the class of monoclonal antibodies directed against aggregated forms of beta amyloid.”