Johnson & Johnson Announces FDA Approval of STELARA for Pediatric Crohn’s Disease
Johnson & Johnson announced that the FDA has approved STELARA (ustekinumab) for the treatment of children aged two years and older with moderately to severely active Crohn’s disease. The approval makes STELARA the first non-TNF biologic and only IL-12/23 inhibitor cleared for use in this pediatric population, addressing a significant gap in treatment options for children with more aggressive disease progression. The decision was supported by Phase 3 UNITI-Jr clinical trial data demonstrating efficacy and a safety profile consistent with adult use, expanding an established therapy into a younger patient group. 
Johnson & Johnson Announces FDA Approval of STELARA for Pediatric Crohn’s Disease