In a somewhat surprising move, the US Food and Drug Administration (FDA) has declined to grant accelerated approval to Eli Lilly’s donanemab
Like aducanumab and lecanemab, which were previously granted accelerated approval by the FDA, donanemab is a monoclonal antibody treatment against the beta amyloid protein that accumulates in the brain of a person with Alzheimer’s disease. Eli Lilly published very promising results for donanemab in 2021, which included demonstration that donanemab could lower amyloid levels in the brain of people with mild cognitive impairment and mild dementia (the basis for accelerated approval). But the number of participants in the study, particularly the number with at least 12 months of data, was apparently not sufficient for the FDA to grant approval.
A Phase 3 clinical trial of donanemab that is intended to test whether the drug is clinically beneficial is under way and could render the FDA decision moot—if donanemab demonstrates efficacy it could be in line for full approval. The results of that trial are expected later this year.