FDA Approves Johnson & Johnson’s Simponi (golimumab) as the First Monthly Maintenance Therapy for Pediatric Ulcerative Colitis

Johnson & Johnson achieved a milestone on October 7, 2025, as the U.S. FDA approved Simponi (golimumab) for pediatric patients aged at least 2 years and weighing at least 15 kg, living with moderately to severely active ulcerative colitis (UC).

This regulatory win makes Simponi the first biologic approved for children in this patient group that can be administered on a once-monthly schedule-helping young patients manage a complex disease with far fewer treatment disruptions.

UC is a chronic, inflammatory bowel condition marked by unpredictable flares of pain, diarrhea, and bleeding, often upending daily activities and emotional well-being for kids and their families. Historically, pediatric UC patients have had limited treatment options.

Simponi’s expanded indication is supported by robust Phase 3 PURSUIT trial data: nearly one-third of pediatric participants achieved remission at week 6. Over half of those who achieved remission at week 6 maintained remission through one year. The safety profile of Simponi in children closely matched that previously documented in adults.

Johnson & Johnson highlighted this approval as a major advancement in addressing unmet needs among children with immune-mediated diseases. Their pediatric R&D teams reaffirm commitment to ongoing innovation, so that safe, effective therapies reach young people living with serious conditions.