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. 2023 Mar 18;17(2):249-258.
doi: 10.1093/ecco-jcc/jjac135.

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

Nicholas M Croft  1 , Lissy de Ridder  2 , Anne M Griffiths  3 , Jeffrey S Hyams  4 , Frank M Ruemmele  5   6 , Dan Turner  7 , Katharine Cheng  8 , Irja Lutsar  9 , Marco Greco  10 , Zuzanna Gołębiewska  11 , Floriane Laumond  12 , Maria Cavaller-Bellaubi  13 , Adam Elgreey  14 , Tara A Altepeter  15 , Chrissi Pallidis  16 , Koen Norga  17 , Robert Nelson  8 , Wallace Crandall  18 , Gilles Vassal  19
Affiliations

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

Nicholas M Croft et al. J Crohns Colitis. .

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.

Keywords: Multi; drug development; paediatric Crohn’s disease and ulcerative colitis; stakeholder discussion.

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Conflict of interest statement

AMG: Consultant to Abbvie, Amgen, BristolMyersSquibb, Janssen, Lilly, Merck, Pfizer. Speaker fees from Abbvie, Janssen, Nestle. Investigator-initiated research support from Abbvie. CP: Is an employee of the European Medicines Agency. FMR: Collaboration [advisory boards, consulting, scientific presentations] with Schering-Plough, Ferring, MSD, Johnson & Johnson, Centocor, AbbVie; Nestlé Nutrition Institute, Nestlé Health Science, Danone, MeadJohnson, Takeda, Celgene, Biogen, Bristol Myers Squibb, Gossamer, Lilly. DT: during last 3 years, has received consultation fee, research grant, royalties or honorarium from Janssen, Pfizer, Hospital for Sick Children, Ferring, AbbVie, Takeda, Atlantic Health, Shire, Celgene, Lilly, Roche, ThermoFisher, Bristol-Meyers Squibb. GV: Provided advice on paediatric oncology drug development to Astra-Zeneca, Bayer, Bristol Meyers Squib, Celgene, Hutchinson-Medi Pharma, Ipsen, Celltrion, Merck, Novartis, Pfizer, Roche/Genentech. He does not accept personal remuneration. GV is also is a board member of SIOP Europe [the European Society for Paediatric Oncology]. JSH: Advisory board for Janssen, AbbVie. Consultant to Lilly, Boehringer Ingelheim, Bristol Myers Squibb, Thetis, Takeda, Pfizer. KC: Is an employee of Janssen, UK. KN: Is an employee of the European Medicines Agency. LdR: Collaboration [such as involved in industry-sponsored studies, investigator-initiated study, consultancy] with Celltrion, AbbVie, Eli Lilly, Takeda, Pfizer. AE, FL, IL, MC-B, MG, ZG: None. NMC: Trial funding, advisory board and speakers fees paid to his institution from AbbVie, Eli Lilly, Takeda, Shire, Pfizer, Janssen. RN: Is an employee of Johnson & Johnson. TAA: Is an employee of the US Food and Drugs Administration. WC: Is an employee of Eli Llly and Company. As well as the authors declaration of interests, participants of the 2-day meeting included employees of AbbVie, AstraZeneca, Boehringer Ingelheim, Eli Lilly & Company, GSK, Janssen, Johnson & Johnson, OSE Immunoth, Pfizer, Roche Genentech and Servier.

Figures

Figure 1.
Figure 1.
Issues leading to delayed paediatric approvals of innovative drugs being developed for adults with IBD.
See this image and copyright information in PMC

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