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News
The FDA has approved Stelara (ustekinumab) for children aged 2 and older with moderate to severe ulcerative colitis, making it the first non-TNF-targeting monoclonal antibody approved for both pediatric UC and Crohn's disease. The decision was backed by the UNIFI Jr. trial, which showed meaningful remission and endoscopic improvement rates in kids. This marks a significant expansion of treatment options for young IBD patients.
The FDA has approved Stelara (ustekinumab, Janssen) for the treatment of moderately to severely active ulcerative colitis in children aged 2 and older — completing a landmark double approval that now covers both major forms of pediatric inflammatory bowel disease. Earlier this year, the agency had already greenlit the drug for pediatric Crohn's disease in the same age group, making ustekinumab the first non-TNF-targeting monoclonal antibody approved for both conditions in kids.
The approval was supported by pharmacokinetic and safety data from adult UC trials, pediatric CD studies, and the 52-week UNIFI Jr. trial involving 112 children (ages 3–17) with moderate to severe UC. After a single IV induction dose, 79 patients achieved clinical response at week 8 and proceeded to maintenance therapy.
By the Numbers:
Why it matters: With limited approved therapies for pediatric IBD, this dual approval gives clinicians a well-tolerated, non-TNF option for young patients with both UC and Crohn's disease — a meaningful step forward in managing these chronic, life-altering conditions in children.
