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

Overview

Journal J Crohns Colitis

Publisher Oxford University Press

Date 2022 Sep 21

PMID 36130314

Authors

Nicholas M Croft

Lissy de Ridder

Anne M Griffiths

Jeffrey S Hyams

Frank M Ruemmele

Dan Turner

Katharine Cheng

Irja Lutsar

Marco Greco

Zuzanna Golebiewska

Floriane Laumond

Maria Cavaller-Bellaubi

Adam Elgreey

Tara A Altepeter

Chrissi Pallidis

Koen Norga

Robert Nelson

Wallace Crandall

Gilles Vassal

Affiliations

Soon will be listed here.

Abstract

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.

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