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Kisunla (donanemab) — EU Marketing Authorization (EPAR), following CHMP re-examination
European Medicines Agency, 2025-09-24
Topic: Brain proteins, microglia and lab models
The EMA initially recommended against approving donanemab in March 2025, again on ARIA risk-benefit grounds, then reversed itself after re-examination: the CHMP issued a positive opinion on July 24, 2025, and the European Commission granted marketing authorization on September 24, 2025, restricted to early-Alzheimer's patients with one or no copy of the ApoE4 gene. The EU label excludes patients on anticoagulants, with uncontrolled bleeding disorders, prior brain bleeds, more than 4 microbleeds, or poorly controlled high blood pressure, and caps treatment at 18 months.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Kisunla (donanemab) — EU Marketing Authorization (EPAR), following CHMP re-examination. (2025). European Medicines Agency.
Vancouver
Kisunla (donanemab) — EU Marketing Authorization (EPAR), following CHMP re-examination. European Medicines Agency. 2025.
BibTeX
@article{study2025-87b2f0ae,
title = {{Kisunla (donanemab) — EU Marketing Authorization (EPAR), following CHMP re-examination}},
journal = {European Medicines Agency},
year = {2025}
}
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.
Key findings
- Initial CHMP negative opinion (March 2025) reversed to a positive opinion after re-examination (July 24, 2025); EU authorization granted September 24, 2025
- Restricted to ApoE4 heterozygotes/non-carriers with confirmed amyloid pathology
- Contraindicated with anticoagulants, uncontrolled bleeding disorders, prior brain hemorrhage, or more than 4 microbleeds; treatment duration capped at 18 months; mandatory MRI monitoring
Why it matters
The EMA initially recommended against approving donanemab on ARIA risk-benefit grounds, then reversed itself and granted EU authorization restricted to early-Alzheimer's patients with one or no copy of the ApoE4 gene. The EU label excludes several groups including patients on anticoagulants and caps treatment at 18 months.
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Study details
- Study designregulatory decision
- Evidence strengthModerate
Limitations
Regulatory decision document, not primary research; treatment duration capped at 18 months under the EU label.
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 | 2025 — 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 →
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