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.
Subscribe to Journal
Get full journal access for 1 year
only $4.92 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Tax calculation will be finalised during checkout.
Rent or Buy article
Get time limited or full article access on ReadCube.
All prices are NET prices.
US National Library of Medicine. ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02477800 (2020).
US National Library of Medicine. ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02484547 (2020).
US National Library of Medicine. ClincialTrials.gov https://clinicaltrials.gov/ct2/show/NCT01677572 (2020).
Biogen. Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer’s disease. Investors.biogen.com https://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-discontinue-phase-3-engage-and-emerge-trials (2019).
Food and Drug Administration. November 6, 2020 BLA 761178: Peripheral and Central Nervous System Drugs Advisory Committee Meeting. fda.gov https://www.fda.gov/media/143505/download (2020).
Food and Drug Administration. 21 314.126 Adequate and well-controlled studies. Electronic Code of Federal Regulations. https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=eebde221fa5a328fb93261e1fe8a849d&mc=true&n=pt21.5.314&r=PART&ty=HTML#se21.5.314_1126 (2020).
Food and Drug Administration. FDA Manual of Policies and Procedures MAPP 4151.8. fda.gov https://www.fda.gov/media/79353/download (2010).
Food and Drug Administration. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. fda.gov https://www.fda.gov/media/71655/download (1998).
Biogen. Update on FDA advisory committee’s meeting on aducanumab in Alzheimer’s disease. Investors.biogen.com https://investors.biogen.com/news-releases/news-release-details/update-fda-advisory-committees-meeting-aducanumab-alzheimers (2020).
Zhang, A. D., Schwartz, J. L. & Ross, J. S. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions 2008–2015. Milbank Q. 97, 796–819 (2019).
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.
About this article
Cite this article
Fillit, H., Green, A. Aducanumab and the FDA — where are we now?. Nat Rev Neurol 17, 129–130 (2021). https://doi.org/10.1038/s41582-020-00454-9
Current Neurology and Neuroscience Reports (2021)