FDA

Simponi now approved for use in children with ulcerative colitis

October 15, 2025

On October 7, 2025, FDA approved Simponi (golimumab), a tumor necrosis factor (TNF) inhibitor, for the treatment of children with moderately to severely active ulcerative colitis (UC), weighing ≥15 kg.

This is the first pediatric approval for Simponi, which was previously approved for four indications, including adults living with moderate to severe rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and moderately to severely active UC.

Efficacy

Efficacy and safety were evaluated in the multi-center, open-label PURSUIT 2 (NCT03596645). Efficacy was assessed in 66 patients weighing ≥15 kg with moderately to severely active ulcerative colitis defined as a Mayo score of 6 to 12 with an endoscopy subscore of ≥2 who had an inadequate response to corticosteroids, 6‑mercaptopurine (6‑MP), or azathioprine (AZA), or who were intolerant to or had medical contraindications for such therapies. Patients with prior exposure to TNF blockers were ineligible. Of the 66 subjects assessed for efficacy, mean age was 13.4 years (range. 4-17 years), median weight was 51 kg, and 53% were female.

Efficacy was assessed by the Mayo score at weeks 6 and 54.

At 6 weeks, 32% (95% confidence interval [CI], 22-41) of patients achieved the primary endpoint of clinical remission (defined as Mayo score ≤2 points, with no individual subscore >1). In addition, 58% (95% CI, 48-68) achieved the secondary endpoint of clinical response (defines as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1).

Among the 21 patients in clinical remission at week 6, 57% maintained clinical remission at week 54. For those who had a clinical response at week 6, 34% were in clinical remission and 39% had endoscopic improvement (endoscopy subscore of 0 or 1 based on local endoscopy) at week 54.

Safety

Adverse reactions reported in the PURSUIT 2 trial were similar to those reported in clinical trials of adults with UC. Additional adverse reactions reported in ≥10% of pediatric patients in the trial were headache (17%) and pyrexia (10%).

Sources:

Simponi (golimumab) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125289s157lbl.pdf Revised October 2025. Accessed October 14, 2025.

US FDA approves Simponi® (golimumab) for the treatment of pediatric ulcerative colitis. [News release]. 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis