JnJ seeks USFDA nod for Stelara in treatment of pediatric ulcerative colitis
Horsham: Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand approval of STELARA (ustekinumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC).
Ulcerative colitis affects approximately one million people in the U.S., with an increasing rate in the pediatric population, who often experience more severe symptoms than adults.
This submission is supported by data from the Phase 3 UNIFI Jr clinical trial, a multicenter interventional study to evaluate the efficacy, safety, and pharmacokinetics of STELARA for the treatment of pediatric UC through Week 52.
“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.”
STELARA is currently approved for the treatment of adults with moderately to severely active Crohn’s disease and UC, in addition to adults and children six years and older with active psoriatic arthritis and moderate to severe plaque psoriasis. In June 2025, Johnson & Johnson submitted an sBLA to the FDA seeking approval of STELARA for the treatment of children two years and older with moderately to severely active Crohn’s disease.
STELARA is not currently approved in the U.S. to treat moderately to severely active pediatric ulcerative colitis or Crohn’s disease.
