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Aducanumab and the FDA — where are we now?

The amyloid antibody aducanumab is currently undergoing review by the FDA. The treatment would be the first disease-modifying drug to be approved for Alzheimer disease; however, a medical advisory committee recently convened by the FDA did not recommend approval, raising questions about whether the existing evidence of efficacy is sufficient.

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Correspondence to Howard Fillit.

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Competing interests

H.F. has been a paid or unpaid consultant to Alector, Biogen, Genentech, Lilly, Lundbeck, Merck, Otsuka, Roche and Samus Therapeutics. H.F. also participated in a "Mock Advisory Committee" meeting with Biogen to review the presentation that was proposed to be given at the FDA Advisory Committee meeting discussed here. In the past month, A.G. has been a paid consultant to Samus Therapeutics.

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Fillit, H., Green, A. Aducanumab and the FDA — where are we now?. Nat Rev Neurol 17, 129–130 (2021).

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