Written By: Sheetal Barbade BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved Simponi (Golimumab) for the treatment of children aged two years and older with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kg. The approval, announced on October 7, 2025, marks the first pediatric indication for Simponi in the United States, expanding its use beyond adult ulcerative colitis and other autoimmune diseases. The approval was granted to Johnson & Johnson Innovative Medicine
About Simponi (Golimumab)
Simponi (Golimumab) is a fully human monoclonal antibody that targets and neutralizes tumor necrosis factor-alpha (TNF-α), a cytokine involved in inflammatory and immune-mediated processes. By binding to both soluble and transmembrane forms of TNF-α, Golimumab reduces inflammation, mucosal injury, and immune system activation characteristic of ulcerative colitis. The drug is administered as a subcutaneous injection through a prefilled syringe, with dosing determined by patient body weight. For children weighing between 15 and 40 kg, the regimen includes 100 mg at week 0, 50 mg at weeks 2 and 6, and every four weeks thereafter. Patients weighing 40 kg or more receive 200 mg at week 0, 100 mg at weeks 2 and 6, and every four weeks subsequently. For adolescents aged 12 years and above, self-administration may be possible following appropriate training.
About Ulcerative Colitis
Ulcerative colitis is a chronic, relapsing inflammatory bowel disease (IBD) characterized by inflammation and ulceration of the colon lining. In children, UC tends to have a more aggressive course, with higher rates of relapse, greater disease extent, and risk of growth impairment. Pediatric UC management is particularly challenging due to limited approved biologic options. Before this approval, Simponi was indicated only for adults with UC, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The pediatric extension brings new hope for improved disease control and quality of life in younger patients.
Clinical Evidence Supporting the Approval
The FDA’s decision was supported by data from pediatric studies conducted under the PURSUIT (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment) program Pursuit 2 Study (NCT03596645) and Pursuit Pediatric P Study (NCT01900574). The evidence included a Phase 1 pharmacokinetic study that evaluated drug exposure and safety in children, and a Phase 3 open-label trial assessing clinical remission, response, and endoscopic outcomes. At Week 6, 32% of pediatric participants achieved clinical remission (Mayo score ≤2 with no subscore >1), while 58% showed clinical response and 40% demonstrated endoscopic improvement. Among those who achieved remission at Week 6, 57% maintained remission through Week 54 with continued Golimumab therapy. These outcomes underscore Simponi’s potential to induce and sustain remission in children with moderate to severe UC.
Safety Profile
As with other TNF-α inhibitors, Simponi carries risks that require careful monitoring, particularly in pediatric patients. Reported adverse effects include serious infections such as tuberculosis, sepsis, and opportunistic infections, necessitating screening for latent TB prior to initiation. There is a noted risk of malignancy, including lymphoma, especially in pediatric or adolescent patients receiving concomitant immunosuppressants. Other potential adverse events include reactivation of hepatitis B, hematologic abnormalities, heart failure exacerbation, and injection-site reactions. Live vaccines should be avoided during therapy, and clinicians are advised to maintain long-term vigilance regarding infection risk, immune suppression, and growth impacts.
Physician should also implement caution in patients with a history of demyelinating disorders such as multiple sclerosis or Guillain-Barre syndrome, as TNF-α blockade has been associated with rare cases of new-onset or worsening neurological symptoms.
Physician Instructions before Prescribing
Before initiating Simponi in pediatric patients, physicians should consider the following clinical steps:
Screen for infections: Evaluate for latent or active tuberculosis, hepatitis B, and other chronic infections before starting therapy.
Review immunization status: Ensure all age-appropriate vaccines are completed; live vaccines should be avoided during and after therapy.
Conduct baseline investigations: Include complete blood count, liver and renal function tests, and screening for potential hematologic or hepatic disorders.
Assess concurrent medications: Evaluate use of immunosuppressants such as azathioprine or 6-mercaptopurine to minimize combined toxicity or malignancy risk.
Monitor growth and development: Record baseline height, weight, and nutritional status since prolonged inflammation and therapy may affect growth.
Educate caregivers: Provide guidance on recognizing signs of infection, allergic reactions, or unusual fatigue, bruising, or fever.
Plan multidisciplinary follow-up: Coordinate care with pediatric gastroenterology and infectious disease specialists for ongoing evaluation and safety monitoring.
Key Opinions
Dr. Chris Gasink, M.D., Vice President of Medical Affairs, Gastroenterology & Autoantibody at Johnson & Johnson Innovative Medicine, stated that the FDA approval of Simponi represents a significant milestone in pediatric inflammatory bowel disease care. He emphasized that the therapy brings together a well-established efficacy and safety profile with the convenience of subcutaneous dosing, providing a new option for younger patients who have historically faced limited treatment choices for ulcerative colitis.
References
Johnson & Johnson, U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric
Ulcerative colitis, October 7, 2025, Available at: https://www.jnj.com/media-center/press-releases/u- s-fda-approves-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis
Johnson & Johnson submits application seeking U.S. FDA approval of SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis. December 16, 2024. Available at: https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-application-seeking-u- s-fda-approval-of-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis
Simponi Prescribing Information https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf
Hyams JS, O’Brien CD, Padgett L, et al, Maintenance Golimumab Treatment in Pediatric UC Patients With Moderately to Severely Active UC: PURSUIT PEDS PK Long-Term Study Results. Crohns Colitis 360. 2020 Aug 4;2(4):otaa063. Doi: 10.1093/crocol/otaa063. PMID: 36777743; PMCID: PMC9802358.
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients with Moderate to Severe Active Ulcerative Colitis, ClinicalTrials.gov ID NCT01900574, https://clinicaltrials.gov/study/NCT01900574