FDA Approves Ustekinumab for Pediatric Ulcerative Colitis

The U.S. Food and Drug Administration on August 28 approved ustekinumab (Stelara) injection for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years old and older. The agency approved ustekinumab for the treatment of moderately to severely active Crohn’s disease (CD) in pediatric patients aged 2 years old and older earlier this year.

The safety and effectiveness of ustekinumab for the treatment of moderately to severely active UC was supported by evidence from adequate and well-controlled studies in adult subjects with UC, pharmacokinetic and safety data from pediatric subjects with CD aged 2 to 17 years of age, and additional safety, efficacy, and pharmacokinetic data from a 52-week study in 112 pediatric subjects with UC aged 3 to 17 years of age.

The most common adverse reactions in pediatric patients with UC receiving ustekinumab are nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.

Reference:

FDA approves Stelara for pediatric ulcerative colitis. Press release; August 28, 2026. Accessed September 1, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-stelara-pediatric-ulcerative-colitis