Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to seek expanded approval of STELARA (ustekinumab) for treating children aged two years and older with moderately to severely active ulcerative colitis (UC). The company cited rising rates of pediatric UC in the United States, noting that about one million people in the country are affected by UC, with children representing roughly 20 percent of this population.
The application is based on results from the Phase 3 UNIFI Jr clinical trial, which evaluated the efficacy, safety, and pharmacokinetics of STELARA in pediatric patients through Week 52. The study used an open-label intravenous induction treatment followed by randomized double-blind subcutaneous maintenance therapy.
Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody at Johnson & Johnson Innovative Medicine said: “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. 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.”
STELARA is already approved for adults with moderately to severely active Crohn’s disease and UC as well as adults and children six years or older with active psoriatic arthritis or moderate to severe plaque psoriasis. In June 2025, Johnson & Johnson also filed for FDA approval of STELARA for use in children aged two years or older with moderately to severely active Crohn’s disease. These efforts are part of what Johnson & Johnson describes as its commitment to advancing therapies for immune-mediated diseases across different age groups.
Ulcerative colitis is a chronic inflammatory bowel disease where the immune system attacks healthy cells lining the colon. Symptoms include frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, weight loss, fatigue, and loss of appetite.
The Janssen Pharmaceutical Companies of Johnson & Johnson hold exclusive worldwide marketing rights to STELARA.
STELARA is a prescription medication that acts as an interleukin-12 and interleukin-23 antagonist. It affects the immune system and can increase susceptibility to serious infections such as tuberculosis or those caused by bacteria, fungi or viruses; cancer risk; allergic reactions; rare brain conditions like posterior reversible encephalopathy syndrome; lung inflammation; among other potential side effects. Patients should inform healthcare providers about infections or symptoms before starting therapy.
Patients prescribed STELARA are advised to follow their healthcare provider's instructions closely regarding dosage and administration schedules. In pediatric cases especially, injections should be administered under medical supervision unless caregivers receive proper training from healthcare professionals.
Negative side effects from prescription drugs can be reported via https://www.fda.gov/medwatch or by calling 1-800-FDA-1088.
Johnson & Johnson emphasized its focus on innovation within healthcare solutions spanning medicine and medical technology sectors. The company cautioned that forward-looking statements made regarding regulatory submissions involve risks such as uncertainty around clinical success or regulatory approvals.