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Approval expands SIMPONI® indication to treat children weighing at least 15 kg with moderately to severely active ulcerative colitis
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SIMPONI® is the only approved treatment to offer a monthly maintenance dose for this patient population
HORSHAM, Pa. (October 7, 2025) – Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved SIMPONI® (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. This approval builds on the SIMPONI® indication for adults living with moderately to severely active UC, which together represents more than one million Americans living with this condition.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, Medical Affairs, Gastroenterology & Autoantibody, 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.”
The approval is supported by data from the PURSUIT program, which included two multi-center, open-label studies to evaluate the efficacy, safety, and pharmacokinetics of subcutaneously administered SIMPONI® for the treatment of pediatric UC. In the Phase 3 PURSUIT 2 study, the primary endpoint of clinical remission at Week 6 was achieved by 32% of patients. The secondary endpoints of clinical response at Week 6 was achieved by 58% and endoscopic improvement at Week 6 was achieved by 40% of patients receiving SIMPONI®.a,b,c Among patients treated with SIMPONI® who were in clinical remission at Week 6, 57% maintained clinical remission of symptoms at Week 54. Safety results for this population are consistent with clinical trials of SIMPONI® in adults with UC.
SIMPONI® is administered as a pre-filled syringe and can be self-administered for patients aged 12 years and older after proper training by a healthcare 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, SIMPONI® 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 SIMPONI®, which is already 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. This approval is another important milestone for patients and is emblematic of Johnson & Johnson’s continuous commitment to innovating to improve the lives of people living with chronic immune-mediated diseases.
Editor’s Notes:
a. Clinical remission is defined as a Mayo score ≤2 points, with no individual subscore >1.
b. Clinical response is defined 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.
c. Endoscopic remission is defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
ABOUT PEDIATRIC ULCERATIVE COLITIS
Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) in which chronic inflammation of the colon occurs. In UC, the immune system inappropriately attacks and damages healthy cells in the lining of the colon. Patients can experience a range of unpredictable symptoms, which may include loose and more frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue. More than one million people in the U.S. are living with UC, making it one of the largest populations globally affected by this disease, approximately 20 percent of individuals are pediatric.1,2
ABOUT THE PHASE 3 PURSUIT 2 STUDY ( NCT03596645)
PURSUIT 2 is a Phase 3, multi-center open-label study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered SIMPONI® for the treatment of moderately to severely active ulcerative colitis in pediatric patients two years of age and older.
ABOUT THE PHASE 1 PURSUIT PEDIATRIC PK STUDY ( NCT01900574)
PURSUIT Pediatric PK is a Phase 1 open-label study evaluating the safety and pharmacokinetics of subcutaneously administered SIMPONI® for the treatment of moderately to severely active ulcerative colitis in pediatric patients two years of age and older. Participants in clinical response at Week 6 continued in the study extension with golimumab through Week 114.
ABOUT SIMPONI® (golimumab)
Developed by Johnson & Johnson, SIMPONI® is an anti-TNF biologic medicine that targets and blocks a protein called TNF-alpha (tumor necrosis factor-alpha).
SIMPONI® is a prescription medicine approved in the U.S. to treat:
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adults with moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate (MTX)
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adults with active psoriatic arthritis (PsA), alone or with the medicine MTX
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adults with active ankylosing spondylitis (AS)
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adults and children weighing at least 33 pounds (15 kg) with moderately to severely active ulcerative colitis (UC)
SIMPONI® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of the above condition(s).
Johnson & Johnson maintains exclusive worldwide marketing rights to SIMPONI®.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Footnotes
1 Crohn’s & Colitis Foundation of America. The Facts About Inflammatory Bowel Diseases. Accessed September 2025. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
2 Rosen MJ, Dhawan A, Saeed SA. Inflammatory Bowel Disease in Children and Adolescents. JAMA Pediatr. 2015 Nov;169(11):1053-60. doi: 10.1001/jamapediatrics.2015.1982. PMID: 26414706; PMCID: PMC4702263.