An FDA advisory committee has unanimously recommended the approval of donanemab for treating Alzheimer’s disease, highlighting its effectiveness in slowing cognitive decline.

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee vote was favorable, with 11 members voting "yes" and 0 members voting "no."

The FDA convened the advisory committee to evaluate the efficacy and safety data submitted by Eli Lilly and Company. The data included results from a pivotal Phase 3 clinical trial, TRAILBLAZER-ALZ 2, which demonstrated that donanemab, administered to patients with early symptomatic disease, resulted in significant slowing of cognitive decline compared to placebo. The study involved patients with mild cognitive impairment and mild dementia from Alzheimer's. Statistically significant reductions in decline were observed in primary and secondary endpoints, including the integrated Alzheimer’s Disease Rating Scale, Alzheimer’s Disease Assessment Scale – Cognitive Subscale, and the Clinical Dementia Rating – Sum of Boxes.

The advisory committee discussed potential safety concerns, particularly amyloid-related imaging abnormalities (ARIA) and infusion-related reactions. The incidence of ARIA with edema was reported in 24% of patients, and ARIA with hemosiderin deposition in 31% of patients. Two ARIA-related deaths were noted during the trial. The committee ultimately concluded the benefits of donanemab outweighed the risks, especially given the significant unmet need for effective Alzheimer’s treatments.

The panel also reviewed the proposed Risk Evaluation and Mitigation Strategy (REMS), which includes monitoring protocols to manage ARIA and other adverse events. The committee found the REMS plan adequate to address concerns, with recommendations for enhanced patient education and monitoring.

If the FDA follows the committee's recommendation, donanemab will become an approved treatment for early Alzheimer’s disease.