U.S. FDA Approves SIMPONI® (golimumab) for Pediatric Ulcerative Colitis
October 7, 2025 — Horsham, Pa. — Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved SIMPONI® (golimumab) for the treatment of children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kilograms (approximately 33 pounds). This marks an important milestone for pediatric patients who have long faced limited treatment options for this chronic inflammatory bowel disease.
Already approved for adults with ulcerative colitis and other autoimmune conditions, SIMPONI can now be prescribed for younger patients, offering a new therapeutic option with a well-established safety and efficacy profile.
“Ulcerative colitis is especially difficult for children to manage due to limited treatment options,” said Chris Gasink, M.D., Vice President of Medical Affairs, Gastroenterology & Autoantibody at Johnson & Johnson Innovative Medicine. “This FDA approval brings a proven therapy to a population that needs more options, providing consistent efficacy with a convenient subcutaneous dosing schedule.”
Clinical Evidence and Study Results
The FDA approval is supported by results from the Phase 3 PURSUIT clinical program, a multicenter study evaluating the safety, effectiveness, and pharmacokinetics of SIMPONI in children with ulcerative colitis.
At Week 6 of treatment:
- 32% of participants achieved clinical remission
- 58% achieved a clinical response
- 40% demonstrated endoscopic improvement
Among those who achieved remission at Week 6, 57% remained in remission through Week 54.
The safety profile observed in children was consistent with that seen in adult studies, showing no unexpected adverse events.
Recommended Pediatric Dosing
- For patients weighing ≥40 kg: 200 mg at Week 0, 100 mg at Weeks 2 and 6, then every 4 weeks.
- For patients weighing 15 kg to <40 kg: 100 mg at Week 0, 50 mg at Weeks 2 and 6, then every 4 weeks.
The medication is administered via a prefilled syringe, and self-injection is permitted for children aged 12 years or older after proper instruction by a healthcare professional.
This approval represents the first pediatric indication for SIMPONI, expanding its reach beyond adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
About Pediatric Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease that affects the lining of the colon, leading to continuous inflammation and ulcer formation.
The condition results from an overactive immune response that targets the body’s own intestinal tissue, causing symptoms such as:
- Persistent diarrhea or loose stools
- Rectal bleeding
- Abdominal pain and cramping
- Loss of appetite and weight
- Fatigue and malaise
In the United States, more than one million people live with ulcerative colitis, and approximately one in five are diagnosed during childhood or adolescence. For children, the disease can impact growth, nutrition, and overall quality of life, making access to effective treatment especially critical.
Safety Information
SIMPONI is a biologic therapy that targets tumor necrosis factor-alpha (TNF-α), a key protein involved in inflammation. While effective, the medication carries certain risks that must be managed under medical supervision.
Warnings and Precautions
- Serious infections: SIMPONI may increase the risk of bacterial, fungal, or viral infections, including tuberculosis. Patients should be screened for latent TB before starting treatment and monitored during therapy.
- Malignancy risk: TNF blockers have been associated with an increased risk of cancers, including lymphoma, particularly in younger males or patients receiving other immunosuppressants.
- Heart failure: New or worsening heart failure has been reported in some users.
- Nervous system disorders: Rare cases of multiple sclerosis, Guillain-Barré syndrome, and similar conditions have been observed.
- Other effects: Possible liver toxicity, blood disorders, and severe allergic reactions.
Common Side Effects
- Upper respiratory infections
- Injection-site reactions
- Viral infections
- Rash and minor skin irritation
Patients are advised to discuss any existing medical conditions, infections, medications, or vaccination history with their healthcare provider before beginning treatment. Pregnant or breastfeeding individuals should consult their doctor prior to use.
About SIMPONI® (golimumab)
SIMPONI is an anti-TNF biologic developed by Janssen Biotech, a Johnson & Johnson company. It works by inhibiting the activity of tumor necrosis factor alpha (TNF-α), which drives inflammation in autoimmune diseases.
The medication is approved in several regions worldwide for multiple chronic inflammatory conditions, including:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
With this new indication, SIMPONI becomes a valuable treatment option for pediatric ulcerative colitis patients who require biologic therapy to control disease activity and maintain remission.
About Johnson & Johnson Innovative Medicine
Johnson & Johnson Innovative Medicine focuses on developing breakthrough therapies in immunology, oncology, neuroscience, and other key medical fields. The company’s mission is to transform the trajectory of health for humanity, driving innovation that improves outcomes for patients across all stages of life.
Through research partnerships and long-term clinical programs, Johnson & Johnson continues to advance the science of immune-mediated diseases and provide new hope for patients living with chronic conditions like ulcerative colitis.
