TY - JOUR
T1 - Paediatric Inflammatory Bowel Disease
T2 - A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents
AU - Croft, Nicholas M.
AU - De Ridder, Lissy
AU - Griffiths, Anne M.
AU - Hyams, Jeffrey S.
AU - Ruemmele, Frank M.
AU - Turner, Dan
AU - Cheng, Katharine
AU - Lutsar, Irja
AU - Greco, Marco
AU - Gołȩbiewska, Zuzanna
AU - Laumond, Floriane
AU - Cavaller-Bellaubi, Maria
AU - Elgreey, Adam
AU - Altepeter, Tara A.
AU - Pallidis, Chrissi
AU - Norga, Koen
AU - Nelson, Robert
AU - Crandall, Wallace
AU - Vassal, Gilles
N1 - Publisher Copyright:
© 2022 The Author(s). Published by Oxford University Press on behalf of European Crohn's and Colitis Organisation.
PY - 2023/2/1
Y1 - 2023/2/1
N2 - 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.
AB - 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.
KW - Multi
KW - drug development
KW - paediatric Crohn's disease and ulcerative colitis
KW - stakeholder discussion
UR - http://www.scopus.com/inward/record.url?scp=85150665432&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jjac135
DO - 10.1093/ecco-jcc/jjac135
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C2 - 36130314
AN - SCOPUS:85150665432
SN - 1873-9946
VL - 17
SP - 249
EP - 258
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 2
ER -