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Can we learn lessons from the FDA's approval of aducanumab?
Liu KY, Howard R.. Nature reviews. Neurology, 2021-09-17
Topic: Risk, prevention and care in population studies
On 7 June 2021, aducanumab was granted accelerated approval for the treatment of Alzheimer disease (AD) by the FDA on the basis of amyloid-lowering effects considered reasonably likely to confer clinical benefit. This decision makes aducanumab the first new drug to be approved for the treatment of AD since 2003 and the first drug to ever be approved for modification of the course of AD. Many have questioned how scientific evidence, expert advice and the best interests of patients and families were considered in the approval decision.
Key findings
- This decision makes aducanumab the first new drug to be approved for the treatment of AD since 2003 and the first drug to ever be approved for modification of the course of AD.
- Many have questioned how scientific evidence, expert advice and the best interests of patients and families were considered in the approval decision.
- In this article, we argue that prior to approval, the FDA and Biogen's shared interpretation of clinical trial data - that high-dose aducanumab was substantially clinically effective - avoided conventional scientific scrutiny, was prominently advanced by patient representative groups who had been major recipients of Biogen funds, and raised concerns that safeguards were insufficient to mitigate regulatory capture within the FDA.
- Here, we reflect on events leading to the FDA's decision on 7 June 2021 and consider whether any lessons can be learned for the field.
Why it matters
This article discusses the FDA's 2021 accelerated approval of aducanumab based on amyloid-lowering effects considered reasonably likely to confer clinical benefit, and notes that many questioned how the evidence and patients' best interests were weighed. It raises doubts about the approval rather than showing that aducanumab cures or prevents Alzheimer disease.
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Study details
- Evidence strengthLow
How this study scored 46/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Nature reviews. Neurology) |
| Journal's citation record | 3 / 4 | Nature Reviews Neurology: journal h-index 269 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 5 / 7 | Cited 103 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 14.7 citations a year over 7 year(s) since 2021 |
| Impact for its field and year | 3 / 6 | Cited 3.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 5 other studies in this library |
| Still being cited | 2 / 4 | Cited 40 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Robert Howard: h-index 95 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | University College London: institution h-index 2,029 (OpenAlex) |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 1 institution(s) in 1 country — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 34535787) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 46 / 100 | — |
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Read the original
- DOI: 10.1038/s41582-021-00557-x
- PubMed: 34535787
- Original source →
- Free full text: UCL Discovery (University College London) →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
Liu, K. Y., & Howard, R. (2021). Can we learn lessons from the FDA's approval of aducanumab? Nature reviews. Neurology. https://doi.org/10.1038/s41582-021-00557-x
Vancouver
Liu KY, Howard R. Can we learn lessons from the FDA's approval of aducanumab? Nature reviews. Neurology. 2021. doi:10.1038/s41582-021-00557-x. PMID: 34535787.
BibTeX
@article{liu2021-34535787,
author = {Liu, K. Y. and Howard, R.},
title = {{Can we learn lessons from the FDA's approval of aducanumab?}},
journal = {Nature reviews. Neurology},
year = {2021},
doi = {10.1038/s41582-021-00557-x},
pmid = {34535787},
url = {https://doi.org/10.1038/s41582-021-00557-x}
}
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