Johnson & Johnson announced FDA’s decision to approve Simponi for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 33 lbs. The approval expands upon Simponi’s approved indication for adults living with moderately to severely active UC.¹

“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,” said Chris Gasink, M.D., vice president of medical affairs, gastroenterology & autoantibody at Johnson & Johnson Innovative Medicine. “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.”

What is FDA’s approval based off?

FDA’s approval of Simponi is supported by data collected from the Pursuit Program, which included two multi-center, open-label studies evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered Simponi for the treatment of pediatric UC.¹ In the Phase III Pursuit II study, 32% of patients achieved the study’s primary endpoint of clinical remission by week 6, along with the secondary endpoints of clinical response, with 58% of participants reaching clinical remission by week 6 and 40% reaching endoscopic improvement at Week 6. ¹ 57% of study participants treated with Simponi, who were in clinical remission at Week 6, maintained clinical remission of symptoms at Week 54. Safety results for this population remained consistent with clinical trials of Simponi in adults with UC.

Simponi is an anti-TNF biologic medicine targeting and blocking TNF-alpha (tumor necrosis factor-alpha) protein developed by Johnson & Johnson. The medication is also approved in Europe, Canada, Japan, and other countries for the treatment of adults with moderate to severe rheumatoid arthritis with the medicine methotrexate, adults with active psoriatic arthritis alone or with the medicine MTX, adults with active ankylosing spondylitis, and adults and children weighing at least 33 lbs. with moderately to severely active UC.¹

Simponi is administered as a pre-filled syringe and can be self-administered for patients 12 years and older, following proper training by a healthcare provider. Simponi’s suggested beginning dosage for pediatric patients weighing at least 88 lbs. is 200 mg, followed by 100 mg at Weeks 2 and 6, and then another 100mg every 4 weeks after initial dosage.¹ Pediatric patients weighing between 33 lbs. and 88 lbs., are suggested to begin initial dosage at 100mg , followed by 50 mg at the week 2 and 6 interval, and then additional dosage should be administered every 4 weeks following.

This marks the first pediatric approval for Simponi which is already approved for four indications, The approval marks an important milestone for patients and also shows Johnson & Johnson’s commitment to innovating to improve the lives of people living with chronic immune-mediated diseases.¹

Sources

1. U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis Johnson and Johnson October 7, 2025 https://www.jnj.com/media-center/press-releases/u-s-fda-approves-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis