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

Nicholas M Croft1, Lissy de Ridder2, Anne M Griffiths3

  • 1Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK.

Journal of Crohn'S & Colitis
|September 21, 2022
PubMed

Insights

New therapies for pediatric inflammatory bowel disease (IBD) face significant approval delays. Collaborative efforts are needed to expedite the development and accessibility of these crucial IBD treatments for children.

Area of Science:

  • Gastroenterology and Hepatology
  • Pediatric Pharmacology
  • Regulatory Science

Background:

  • Limited advanced treatment options exist for pediatric inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis.
  • A significant delay, averaging 7 years, exists between adult and pediatric drug approvals for IBD.
  • Despite regulatory pathways for pediatric studies, timely drug access for children remains a challenge.

Purpose of the Study:

  • To discuss multi-stakeholder perspectives on developing new drugs for pediatric IBD.
  • To identify and propose actions for expediting the approval of novel IBD therapies in children.

Main Methods:

  • A 2-day virtual multi-stakeholder meeting was convened.
  • Participants included clinical academics, patient representatives, pharmaceutical industry professionals, and regulatory agency members.
  • Discussions focused on current challenges and potential solutions in pediatric IBD drug development.

Main Results:

  • Key perspectives from diverse stakeholders on pediatric IBD drug development were presented and discussed.
  • Actionable strategies to accelerate the approval process for new pediatric IBD medications were proposed.
  • The need for enhanced collaboration among all parties involved was highlighted.

Conclusions:

  • Expediting drug approval for pediatric IBD requires coordinated action from all stakeholders.
  • Facilitating the development and accessibility of new IBD therapies for children is a critical unmet need.
  • Continued multi-stakeholder engagement is essential for advancing pediatric IBD treatment options.
Abstract

Keywords:
Multidrug developmentpaediatric Crohn’s disease and ulcerative colitisstakeholder discussion

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