FDA Approves Stelara for Pediatric Ulcerative Colitis

The U.S. Food and Drug Administration has approved Stelara (ustekinumab) injection for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years old and older. On April 15, 2026, Stelara was approved for the treatment of moderately to severely active Crohn’s disease (CD) in pediatric patients aged 2 years old and older. Stelara is the first approved therapeutic monoclonal antibody that does not target human tumor necrosis factor alpha (TNFα) for the two main forms of pediatric inflammatory bowel disease.

This new pediatric therapy delivers on the Trump Administration’s Make America Healthy Again Initiative - the bold executive action to confront the childhood chronic disease crisis head on.

Condition 

Pediatric inflammatory bowel disease (IBD) is a chronic condition in which there is ongoing inflammation in the digestive tract. There are two main forms of pediatric IBD: UC and CD. UC affects the innermost lining of the large intestine and rectum. UC can cause symptoms of bleeding, diarrhea, and an urgent need to use the bathroom. CD can affect any part of the digestive tract, and the inflammation may penetrate deep into the walls of the intestine. CD can cause symptoms of abdominal pain, diarrhea, poor growth, and weight loss and can cause complications such as blockages, and fistulas.

Data Supporting Stelara

The safety and effectiveness of Stelara 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.

Safety Information

The most common adverse reactions in pediatric patients with UC receiving Stelara are nasopharyngitis (common cold), headache, abdominal pain, influenza, fever, diarrhea, sinusitis (sinus infection), fatigue, and nausea.

Designation

Stelara received Orphan Drug Designation for this indication. Approval was granted to Janssen Biotech, Inc.