- sBLA submitted to FDA for STELARA in pediatric ulcerative colitis.
- Phase 3 UNIFI Jr trial supports the application.
- STELARA targets IL-12 and IL-23 in immune-mediated diseases.
- UC affects over one million in the U.S., 20% are pediatric.
FDA Submission for STELARA
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA to expand the use of STELARA (ustekinumab) for treating children aged two and older with moderately to severely active ulcerative colitis (UC).
Clinical Trial Support
The submission is backed by data from the Phase 3 UNIFI Jr clinical trial, which evaluated the efficacy, safety, and pharmacokinetics of STELARA in pediatric UC patients over 52 weeks.
Current Approvals and Applications
STELARA is already approved for adults with Crohn’s disease and UC, and for adults and children six years and older with psoriatic arthritis and plaque psoriasis. In June 2025, an sBLA was also submitted for pediatric Crohn’s disease.
Ulcerative Colitis Overview
UC is a form of inflammatory bowel disease causing chronic inflammation of the colon, affecting over one million people in the U.S., with 20% being pediatric cases. Symptoms include frequent bowel movements, rectal bleeding, diarrhea, abdominal pain, and fatigue.
