FDA Approves Stelara for Pediatric Ulcerative Colitis

The FDA approved Stelara (ustekinumab) on August 28, 2026 for moderately to severely active ulcerative colitis in pediatric patients aged 2 and older. This marks the first non-TNFα biologic approved for pediatric IBD. Approval was supported by the Phase 3 UNIFI Jr trial (NCT04630028), which enrolled 112 pediatric patients aged 3–17. The drug uses a weight-based IV induction dose followed by subcutaneous maintenance every 8 weeks. Stelara targets the shared p40 subunit of IL-12 and IL-23. It received Orphan Drug Designation for this indication. The sBLA was submitted by Johnson & Johnson's Janssen Biotech on October 31, 2025. The most common adverse reactions included nasopharyngitis, headache, abdominal pain, and influenza. UC affects approximately 1 million Americans, with nearly 20% of cases occurring in children.