Paediatric Inflammatory Bowel Disease: A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents

Nicholas M. Croft*, Lissy de Ridder, Anne M. Griffiths, Jeffrey S. Hyams, Frank M. Ruemmele, Dan Turner, Katharine Cheng, Irja Lutsar, Marco Greco, Zuzanna Gołębiewska, Floriane Laumond, Maria Cavaller-Bellaubi, Adam Elgreey, Tara A. Altepeter, Chrissi Pallidis, Koen Norga, Robert Nelson, Wallace Crandall, Gilles Vassal

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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BACKGROUND AND AIMS: Despite recent approvals for new drugs to treat adults with Crohn's disease or ulcerative colitis, there are only two approved advanced treatment options [infliximab and adalimumab] for children with inflammatory bowel disease [IBD]. There are many potential new therapies being developed for adult and paediatric IBD. Moreover, regulatory agencies in both the European Union and USA have processes in place to support the early planning and initiation of paediatric studies. Nevertheless, unacceptable delays in approvals for use of drugs in children persist, with an average 7-year gap, or longer, between authorization of new IBD drugs for adults and children. METHODS: A 2-day virtual meeting was held during April 14-15, 2021 for multi-stakeholders [clinical academics, patient community, pharmaceutical companies and regulators] to discuss their perspectives on paediatric drug development for IBD. RESULTS: The multi-stakeholder group presented, discussed and proposed actions to achieve expediting the approval of new drugs in development for paediatric IBD. CONCLUSIONS: Collaborative action points for all stakeholders are required to make progress and facilitate new drug development for children with IBD.

Original languageEnglish
Pages (from-to)249-258
Number of pages10
JournalJournal of Crohn's & colitis
Issue number2
Publication statusPublished - 1 Feb 2023

Bibliographical note

Funding Information:
This work was supported by the Collaborative Network for European Clinical Trials for Children [conect4children; c4c], including medical writing support, and has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 777389. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations.

Publisher Copyright:
© 2022 The Author(s). Published by Oxford University Press on behalf of European Crohn's and Colitis Organisation.


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