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Leqembi Recommended for Treatment of Early Alzheimer's Disease (CHMP re-examination, reversing July 2024 refusal)
European Medicines Agency, 2024-11-14
Topic: Amyloid, tau and blood-test diagnosis
The EMA's human medicines committee (CHMP) initially refused to approve lecanemab in the EU in July 2024, judging that its modest effect on cognitive decline did not outweigh ARIA risk in the broad early-Alzheimer's population studied. After Eisai requested a re-examination focused on a lower-risk subgroup (people with one or no copies of the ApoE4 gene, about 1,521 of the 1,795 Clarity AD participants), the CHMP reversed course in November 2024 and recommended approval limited to that narrower group, with mandatory MRI monitoring before the 5th, 7th, and 14th doses.
Key findings
- July 2024: CHMP issued a negative opinion for broad use, citing ARIA risk outweighing modest cognitive benefit
- November 14, 2024: CHMP reversed itself, recommending approval only for patients with one or no copy of the ApoE4 gene (reduced ARIA risk subgroup)
- Approval conditioned on an EU-wide safety registry and mandatory MRI scans before treatment and before doses 5, 7, and 14
Why it matters
The EMA committee initially refused to approve lecanemab in the EU, judging its modest cognitive benefit did not outweigh ARIA risk, then reversed course and recommended approval limited to people with one or no copies of the ApoE4 gene. Approval was conditioned on an EU-wide safety registry and mandatory MRI scans before treatment and before doses 5, 7, and 14.
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Study details
- Study designregulatory decision
- Evidence strengthModerate
Limitations
Regulatory decision document, not primary research; reversed an earlier negative CHMP opinion; the cited subgroup is part of the Clarity AD trial already counted separately (see clarity-ad-lecanemab-nejm-2023), so its N is not double-counted here.
How this study scored 15/100
Regulatory decision — not a study. It scored 15 on the same rubric, which is below the 16 cap we apply to non-peer-reviewed sources. Scored zero for study design, sample size, effect reported, studied in people, randomised / blinded and indexed in PubMed because the record does not state it. We have no data on times cited, citations per year, impact for its field and year, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 10 of the 66 points we could judge it on, which is 15 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 2 / 10 | Tier 4 — not a peer-reviewed journal (European Medicines Agency) |
| Journal's citation record | 0 / 4 | Not a journal article, so the journal's record does not count |
| Study design | 0 / 12 | Design recorded as “regulatory decision”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 3 / 5 | Rated “moderate” in our summary |
| Peer-review validation | 1 / 10 | Regulatory decision — not a study. Named source is a regulator (FDA / EMA / CMS / SEC). |
| How recent | 4 / 5 | 2024 — within 3 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 | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| 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 | 0 / 6 | No other study in this library cites it |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 0 / 2 | No PubMed ID and no DOI — scores zero (not stated in the record — scored 0) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 10 / 66 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 10 of the 66 points we could judge it on is 15 out of 100. |
| Total | 15 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. This record has no authors, DOI, so the citation leaves them out. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
Leqembi Recommended for Treatment of Early Alzheimer's Disease (CHMP re-examination, reversing July 2024 refusal). (2024). European Medicines Agency.
Vancouver
Leqembi Recommended for Treatment of Early Alzheimer's Disease (CHMP re-examination, reversing July 2024 refusal). European Medicines Agency. 2024.
BibTeX
@article{study2024-6280b4fa,
title = {{Leqembi Recommended for Treatment of Early Alzheimer's Disease (CHMP re-examination, reversing July 2024 refusal)}},
journal = {European Medicines Agency},
year = {2024}
}
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