New medicines for childhood-onset systemic lupus erythematosus: an EU perspective on paediatric drug development

New medicines for childhood-onset systemic lupus erythematosus: an EU perspective on paediatric drug development

Childhood-onset systemic lupus erythematosus (cSLE, also known as juvenile or paediatric SLE) is a severe autoimmune disease affecting multiple organs and systems, with higher morbidity and severity compared to adult SLE (aSLE). The European Union’s Paediatric Regulation No. 1901/2006 mandates the a...

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Bibliographic Details
Main Authors: Roberto De Lisa, Fernando de Andres-Trelles, Ralph Bax, Sara Galluzzo, Brian Alward, Andrew Thomson, Dominik Karres, Hermine I. Brunner, Nicolino Ruperto, Gunter F. Egger
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Medicine
Subjects:
paediatric systemic lupus erythematosus
childhood systemic lupus erythematosus
paediatric extrapolation
paediatric drug development
paediatric medicine development
European Medicines Agency
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1583140/full
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https://www.frontiersin.org/articles/10.3389/fmed.2025.1583140/full

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