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FDA Approves Treatment for Adults with Alzheimer's Disease (Kisunla / donanemab-azbt)
U.S. Food and Drug Administration, 2024-07-02
Topic: Amyloid, tau and blood-test diagnosis
The FDA approved donanemab (Kisunla) as a monthly IV infusion for people with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia) with confirmed amyloid plaques. Approval was based on a trial of 1,736 patients (860 donanemab, 876 placebo) showing a statistically significant slowing of clinical decline through week 76. Like other anti-amyloid drugs, it carries a boxed warning for ARIA, and the most common side effects were ARIA and headache.
Key findings
- Trial enrolled 1,736 participants; donanemab group showed statistically significant reduction in clinical decline vs placebo on multiple cognitive/functional scales at Week 76
- Boxed warning for ARIA (brain swelling and microbleeds); higher incidence in ApoE ε4 homozygotes
- Third monoclonal antibody approved in this drug class, given every 4 weeks by infusion
Why it matters
Donanemab was approved for early symptomatic Alzheimer's disease based on a trial of 1,736 patients showing statistically significant slowing of clinical decline through week 76. Like other anti-amyloid drugs, it carries a boxed warning for ARIA, with higher incidence in ApoE ε4 homozygotes.
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Study details
- Study designregulatory decision
- Evidence strengthModerate
Limitations
Regulatory press release, not primary research; underlying efficacy/safety data captured separately (see trailblazer-alz2-donanemab-jama-2023).
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 (U.S. Food and Drug Administration) |
| 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
FDA Approves Treatment for Adults with Alzheimer's Disease (Kisunla / donanemab-azbt). (2024). U.S. Food and Drug Administration.
Vancouver
FDA Approves Treatment for Adults with Alzheimer's Disease (Kisunla / donanemab-azbt). U.S. Food and Drug Administration. 2024.
BibTeX
@article{study2024-7f8e71c0,
title = {{FDA Approves Treatment for Adults with Alzheimer's Disease (Kisunla / donanemab-azbt)}},
journal = {U.S. Food and Drug Administration},
year = {2024}
}