Comment by European Alzheimer's Disease Consortium (EADC) investigators on the negative recommendation of the CHMP on the marketing authorization of donanemab for early Alzheimer' s disease
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00159816%3A_____%2F25%3A00082450" target="_blank" >RIV/00159816:_____/25:00082450 - isvavai.cz</a>
Alternative codes found
RIV/00216224:14110/25:00142215 RIV/00216208:11130/25:10499544 RIV/00064203:_____/25:10499544
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S227458072500202X" target="_blank" >https://www.sciencedirect.com/science/article/pii/S227458072500202X</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.tjpad.2025.100259" target="_blank" >10.1016/j.tjpad.2025.100259</a>
Alternative languages
Result language
angličtina
Original language name
Comment by European Alzheimer's Disease Consortium (EADC) investigators on the negative recommendation of the CHMP on the marketing authorization of donanemab for early Alzheimer' s disease
Original language description
The European Medicines Agency's CHMP recently recommended approval of lecanemab but refused marketing authorization for donanemab in early Alzheimer's disease, despite comparable efficacy. We discuss clinical trial data from the TRAILBLAZER-ALZ program, highlighting low rates of severe adverse events, especially in APOE ε4 non-carriers, and potential benefits of donanemab related to lower treatment burden and infusion frequency. We argue that, with appropriate safety measures, donanemab represents a valuable alternative treatment option, and the current regulatory discrepancy warrants reconsideration.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30210 - Clinical neurology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE
ISSN
2274-5807
e-ISSN
2426-0266
Volume of the periodical
12
Issue of the periodical within the volume
8
Country of publishing house
NL - THE KINGDOM OF THE NETHERLANDS
Number of pages
5
Pages from-to
100259
UT code for WoS article
001565649400001
EID of the result in the Scopus database
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