The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis (UC) and pediatric Crohn’s disease (CD), two types of inflammatory bowel disease (IBD).
The guidance addresses study population, study design, efficacy considerations, and safety assessments. The guidance does not address extraintestinal manifestations, stricturing or fistulizing disease, or treatment of long-term complications of pediatric UC or CD.
FDA has approved three classes of medications for pediatric IBD: steroids (budesonide), mesalamines, and anti-TNF agents (infliximab, adalimumab), according to an agency spokesperson.
In the EU, a study found that there are “unacceptable delays,” or a 7-year gap, between authorizing new IBD drugs for adults and children, according to an article that appeared in the February 2023 issue of the Journal of Crohn’s and Colitis…
