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Accelerated Approval of Aducanumab: Where Do We Stand Now?
Barenholtz Levy H.. The Annals of pharmacotherapy, 2021-10-01
Topic: Amyloid, tau and blood-test diagnosis
Aducanumab was approved by the Food and Drug Administration (FDA) in June 2021 to treat Alzheimer disease (AD). Its path to approval has been highly scrutinized, with many experts arguing that the FDA's decision was premature. Accelerated approval was based on a surrogate end point, with evidence to support clinical effectiveness pending a postapproval trial by the drug company sponsor Biogen.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Barenholtz Levy, H. (2022). Accelerated Approval of Aducanumab: Where Do We Stand Now? The Annals of pharmacotherapy. https://doi.org/10.1177/10600280211050405
Vancouver
Barenholtz Levy H. Accelerated Approval of Aducanumab: Where Do We Stand Now? The Annals of pharmacotherapy. 2022. doi:10.1177/10600280211050405. PMID: 34595939.
BibTeX
@article{barenholtzlevy2022-34595939,
author = {Barenholtz Levy, H.},
title = {{Accelerated Approval of Aducanumab: Where Do We Stand Now?}},
journal = {The Annals of pharmacotherapy},
year = {2022},
doi = {10.1177/10600280211050405},
pmid = {34595939},
url = {https://doi.org/10.1177/10600280211050405}
}
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.
Key findings
- Its path to approval has been highly scrutinized, with many experts arguing that the FDA's decision was premature.
- Accelerated approval was based on a surrogate end point, with evidence to support clinical effectiveness pending a postapproval trial by the drug company sponsor Biogen.
- As a result, the role of aducanumab in treating AD remains uncertain.
- A summary of key areas of controversy to guide informed decisions about use of this drug is provided, along with a timeline describing preapproval and postapproval events.
Why it matters
Aducanumab's accelerated approval was based on a surrogate end point, with evidence of clinical effectiveness still pending a postapproval trial by the sponsor Biogen. The paper states that the drug's role in treating Alzheimer's disease remains uncertain.
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Study details
- Evidence strengthLow
How this study scored 35/100
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. We have no data on impact for its field and year and institution's track record, so those were left out: it earned 32 of the 91 points we could judge it on, which is 35 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The Annals of pharmacotherapy) |
| Journal's citation record | 2 / 4 | Annals of Pharmacotherapy: journal h-index 153 (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 | 2022 — 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 | 3 / 7 | Cited 17 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 2.8 citations a year over 6 year(s) since 2022 |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | 1 / 6 | Cited by 2 other studies in this library |
| Still being cited | 1 / 4 | Cited 3 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 1 / 4 | Last-listed author Hedva Barenholtz Levy: h-index 8 (OpenAlex, whole career) |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 0 institution(s) in 0 countries — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 34595939) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 32 / 91 | Scored on 18 of 20 parts. We have no data for the rest, so they are left out: 32 of the 91 points we could judge it on is 35 out of 100. |
| Total | 35 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1177/10600280211050405
- PubMed: 34595939
- Original source →
- Free full text: Annals of Pharmacotherapy →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
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