FDA Advisory Committee recommended that anti-amyloid donanemab is effective for the treatment of patients with early symptomatic Alzheimer's disease
An 11-member advisory panel to the FDA has unanimously concluded that the investigational anti-amyloid donanemab is effective for the treatment of patients with early symptomatic Alzheimer's disease (AD) and that the potential benefits outweigh the risks in this patient population
The June 10 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee was convened specifically to advise the FDA on the safety and efficacy of the drug based on results of the TRAILBLAZER-ALZ 2 trial where donanemab significantly reduced brain amyloid plaque burden and significantly slowed cognitive and functional decline compared with placebo.
After a comprehensive review of the data, the advisory committee voted 11 to 0 in favor of donanemab for treatment of early symptomatic AD (mild cognitive impairment or mild dementia).
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