The U.S. Food and Drug Administration (FDA) approved Johnson & Johnson's Stelara (ustekinumab) injection for moderately to severely active ulcerative colitis (UC). The treatment is for pediatric patients aged two and older.
Stelara becomes the first non-TNF-alpha monoclonal antibody available for both major forms of pediatric inflammatory bowel disease (IBD). The FDA previously approved Stelara for pediatric Crohn's disease in April 2026. This offers a new class of treatment for a patient population with limited advanced therapy options. The indication also received an Orphan Drug Designation from the FDA.
Efficacy and safety data from the Phase 3 UNIFI Jr clinical trial supported the regulatory decision. The trial studied pediatric patients with UC. Evidence from adult studies also provided support.