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. There are many potential new therapies being developed for adult and paediatric inflammatory bowel disease. Moreover, regulatory agencies in both European Union and United States 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 seven-year gap, or longer, between authorisation of new inflammatory bowel disease drugs for adults and children.
A 2-day virtual meeting was held April 14-15, 2021 for multi-stakeholders (clinical academics, patient community, pharmaceutical companies, and regulators) to discuss their perspectives on paediatric drug development for inflammatory bowel disease.
The multi-stakeholder group presented, discussed and proposed actions to achieve expediting the approval of new drugs in development for paediatric inflammatory bowel disease.
Collaborative action points for all stakeholders are required to make progress and facilitate new drug development for children with inflammatory bowel disease.