Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

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.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 1.

    US National Library of Medicine. ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02477800 (2020).

  2. 2.

    US National Library of Medicine. ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02484547 (2020).

  3. 3.

    US National Library of Medicine. ClincialTrials.gov https://clinicaltrials.gov/ct2/show/NCT01677572 (2020).

  4. 4.

    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).

  5. 5.

    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).

  6. 6.

    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).

  7. 7.

    Food and Drug Administration. FDA Manual of Policies and Procedures MAPP 4151.8. fda.gov https://www.fda.gov/media/79353/download (2010).

  8. 8.

    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).

  9. 9.

    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).

  10. 10.

    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).

    Article  Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Howard Fillit.

Ethics declarations

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.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

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

Download citation

Further reading

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing