查看文章

The US licensing of Biogen’s aducanumab as “the first ever disease modifying drug for Alzheimer’s disease” was hailed as a major advance by many. However, in response to the decision, three members of the Food and Drug Administration’s expert independent advisory committee, which voted almost unanimously against approval, resigned, with Harvard professor of medicine Aaron Kesselheim describing it as “probably the worst drug approval decision in recent US history.” 1 Given that existing treatments for Alzheimer’s disease have only marginal benefit at best, 2 what does aducanumab’s controversial approval in the US mean for patients, clinicians, and researchers?

Amyloid protein clumps in the brain (plaques) are a neuropathological feature of Alzheimer’s disease and widely assumed to trigger a cascade of changes that cause cognitive decline. Aducanumab is a monoclonal antibody that removes …