FDA Committee Meeting Will Delay Decision on Donanemab for Early Alzheimer Disease

The Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) is expected to hold a meeting to discuss the phase 3 TRAILBLAZER-ALZ 2 study, which evaluated donanemab for early symptomatic Alzheimer disease. The decision to hold an advisory committee meeting will delay any regulatory action by the FDA beyond the first quarter of 2024.

Donanemab is an investigational antibody therapy that targets a modified form of deposited amyloid-β peptide called N3pG. The randomized, double-blind, placebo-controlled TRAILBLAZER-ALZ 2 study (ClinicalTrials.gov Identifier: NCT04437511) evaluated the efficacy and safety of donanemab in adults 60 to 85 years of age with early symptomatic Alzheimer disease. Study participants were stratified by tau level into either a low/medium or high tau group. 

Findings showed that regardless of tau level, a clinical benefit was observed with donanemab, especially among patients in earlier stages of Alzheimer disease (based on the change from baseline on the integrated Alzheimer Disease Rating Scale). Results also showed significant reductions in brain amyloid plaque levels among patients in the donanemab arm as early as 6 months after initiating treatment. At 12 months, approximately half of all participants achieved predefined criteria of amyloid plaque clearance and were able to stop treatment.

“We are confident in donanemab’s potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease,” said Anne White, executive vice president of Eli Lilly and Company, and president of Lilly Neuroscience. “It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab’s strong efficacy in the context of safety.”

The FDA has yet to set a date for the advisory committee meeting to discuss donanemab.

This article originally appeared on MPR