FDA Approves Golimumab for Pediatric Ulcerative Colitis
The U.S. Food and Drug Administration (FDA) on October 7 approved golimumab for the treatment of children with moderately to severely active ulcerative colitis (UC) who weighat least 15 kg.
The approval is supported by data from the PURSUIT program, which included 2 multicenter, open-label studies to evaluate the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab for pediatric UC. In the Phase 3 PURSUIT 2 study, 32% of patients achieved the primary endpoint of clinical remission at Week 6. The secondary endpoints of clinical response at Week 6 and endoscopic improvement at Week 6 were achieved by 58% and 40%, respectively, of patients who received SC golimumab. Among patients who achieved clinical remission at Week 6 with SC golimumab, 57% maintained clinical remission at Week 54.
Safety results for this population are consistent with clinical trials of golimumab in adults with UC.
Golimumab is administered as a prefilled syringe and can be self-administered for patients aged 12 years and older after proper training by a health care provider. The recommended dosage for pediatric patients weighing at least 40 kg is 200 mg at Week 0, followed by 100 mg at Weeks 2, 6, and every 4 weeks thereafter; for pediatric patients weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at Week 0, followed by 50 mg at Weeks 2, 6, and every 4 weeks thereafter.
This is the first pediatric approval for golimumab, which is already approved for adults with moderately to severely active UC as well as adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.
Reference:
U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis. News release. Johnson & Johnson. October 7, 2025. Accessed October 8, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis
