October 08, 2025
1 min read
The FDA has approved golimumab for the treatment of children with moderately to severely active ulcerative colitis who weigh at least 15 kg.
The approval expands upon the existing golimumab (Simponi, Johnson & Johnson) indication for adults with moderately to severely active ulcerative colitis.
The FDA has approved golimumab for the treatment of children with moderately to severely active ulcerative colitis who weigh at least 15 kg.
According to a press release, this is the first pediatric approval for golimumab, which also is approved for adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.
“Ulcerative colitis is a complex, lifelong condition that is often challenging to manage effectively, particularly for pediatric patients, where relatively few approved options are available,” Chris Gasink, MD, vice president of medical affairs for gastroenterology and autoantibody at Johnson & Johnson Innovative Medicine, said in the release. “The approval of Simponi represents a meaningful milestone, offering a therapy with well-established efficacy and safety along with subcutaneous dosing, for younger patients where treatment options have historically been limited.”
The FDA based its approval on data from the PURSUIT program, which included two multicenter, open-label trials that evaluated the efficacy, safety and pharmacokinetics of golimumab administered subcutaneously for the treatment of ulcerative colitis in children.
In the phase 3, PURSUIT 2 study, 32% of patients who received golimumab achieved the primary endpoint of clinical remission at week 6. More than half of patients (58%) achieved clinical response, and 40% achieved endoscopic improvement, both of which served as secondary endpoints at week 6.
Among patients in clinical remission at week 6 after receiving golimumab, 57% maintained clinical remission of symptoms at week 54.
Safety results were consistent with prior clinical trials of golimumab among adults with ulcerative colitis.
According to the release, golimumab is administered as a prefilled syringe, which can be self-administered after proper training by a health care provider.
The recommended dose for pediatric patients who weigh at least 40 kg is 200 mg at week 0, followed by 100 mg at week 2 and every 4 weeks thereafter. For patients who weigh 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at week 2 and every 4 weeks thereafter.
