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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216224:14110/25:00142215 RIV/00216208:11130/25:10499544 RIV/00064203:_____/25:10499544

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

The European Medicines Agency&apos;s CHMP recently recommended approval of lecanemab but refused marketing authorization for donanemab in early Alzheimer&apos;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.

Název v anglickém jazyce

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

Popis výsledku anglicky

The European Medicines Agency&apos;s CHMP recently recommended approval of lecanemab but refused marketing authorization for donanemab in early Alzheimer&apos;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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30210 - Clinical neurology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE

ISSN

2274-5807

e-ISSN

2426-0266

Svazek periodika

12

Číslo periodika v rámci svazku

8

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

5

Strana od-do

100259

Kód UT WoS článku

001565649400001

EID výsledku v databázi Scopus

—