AI Article Synopsis
- There are only two approved advanced treatment options for children with inflammatory bowel disease (IBD), despite new drugs for adults being available.
- A virtual meeting involving various stakeholders was held to discuss improving the approval process for pediatric IBD drug development.
- Collaborative actions among clinical experts, patient groups, pharmaceutical companies, and regulators are essential to speed up the approval of new medications for children with IBD.
Article 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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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10024546 | PMC |
| http://dx.doi.org/10.1093/ecco-jcc/jjac135 | DOI Listing |
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