Johnson & Johnson announced on October 31, 2025, the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration seeking to expand approval of STELARA® (ustekinumab) for treating children two years and older with moderately to severely active ulcerative colitis. This regulatory filing addresses a significant unmet medical need in pediatric inflammatory bowel disease, where treatment options remain limited.
Clinical Trial Foundation
The FDA submission is supported by data from the Phase 3 UNIFI Jr clinical trial (NCT04630028), a multicenter interventional study designed to evaluate the efficacy, safety, and pharmacokinetics of STELARA for pediatric ulcerative colitis treatment through Week 52. The study employed an open-label intravenous induction treatment followed by randomized double-blind subcutaneous ustekinumab maintenance therapy. Participants who achieved clinical response at Week 8 with ustekinumab were assessed through the full 52-week period.
Addressing Pediatric Treatment Gaps
"Although there have been significant scientific advances in the treatment of inflammatory bowel diseases, many children with ulcerative colitis still face considerable challenges in managing their condition and limited approved treatment options," said Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. "The FDA filing of STELARA in the pediatric population, backed by clinical data and its long-established efficacy and safety profile in existing indications, represents a crucial step toward expanding treatment options and addressing unmet needs in this younger population with relatively few treatments available."
Disease Burden and Patient Population
Ulcerative colitis affects approximately one million people in the United States, with an increasing rate observed in the pediatric population. Approximately 20 percent of individuals with UC are pediatric patients, who often experience more severe symptoms than adults. The condition is characterized by chronic inflammation of the colon, where the immune system inappropriately attacks and damages healthy cells in the colon lining.
Patients can experience a range of unpredictable symptoms, including loose and more frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue. The U.S. represents one of the largest populations globally affected by this disease.
Current STELARA Approvals
STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is currently approved for treating adults with moderately to severely active Crohn's disease and ulcerative colitis. The drug also has approval for adults and children six years and older with active psoriatic arthritis and moderate to severe plaque psoriasis.
Notably, STELARA is not currently approved in the United States to treat moderately to severely active pediatric ulcerative colitis or Crohn's disease. In June 2025, Johnson & Johnson submitted another sBLA to the FDA seeking approval of STELARA for treating children two years and older with moderately to severely active Crohn's disease.
Expanding Pediatric Indications
These pediatric submissions reflect Johnson & Johnson's ongoing commitment to advancing innovative therapies for people with immune-mediated diseases across age groups. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA.
