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Rapid drug access and scientific rigour: a delicate balance

机译:快速药物访问和科学严谨:平衡微妙

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摘要

Despite the substantial burden associated with Alzheimer’s disease, no new pharmacotherapies have been licensed since 2003. Aducanumab, a human monoclonal antibody that targets and reduces β amyloid accumulations in the brain, a defining pathology of Alzheimer’s disease, was considered for approval by the Peripheral and Central Nervous System Drugs Advisory Committee of the US Food Drug Administration (FDA) on Nov 6, 2020. Although a final decision may not be made until March 2021, the process surrounding evaluation ofthis drug has caused controversy.
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