Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved SIMPONI (golimumab) for children with moderately to severely active ulcerative colitis (UC), provided they weigh at least 15 kg. This new approval extends the use of SIMPONI, which was previously indicated for adults with UC.
Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody at Johnson & Johnson Innovative Medicine, said, “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. 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's decision was based on results from the PURSUIT program. In the Phase 3 PURSUIT 2 study, clinical remission at Week 6 was achieved by 32% of patients. Secondary endpoints showed clinical response in 58% and endoscopic improvement in 40% of patients at Week 6. Among those who achieved clinical remission at Week 6 and continued treatment with SIMPONI, 57% maintained remission through Week 54. Safety findings in children were consistent with prior studies in adults.
SIMPONI can be self-administered using a pre-filled syringe for those aged 12 years and older after proper training by a healthcare provider. Dosage varies depending on patient weight: those weighing at least 40 kg receive an initial dose of 200 mg followed by subsequent doses of 100 mg; those between 15 kg and less than 40 kg receive lower dosages on the same schedule.
This marks the first pediatric indication for SIMPONI in the United States. The medication is already approved for four other conditions including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and adult UC.
Ulcerative colitis is an inflammatory bowel disease characterized by chronic inflammation of the colon due to immune system activity against healthy cells lining the colon. Symptoms can include frequent bowel movements, rectal bleeding or bloody stool, diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue. Approximately one million Americans live with UC; about one-fifth are pediatric cases according to data from Crohn’s & Colitis Foundation of America (source).
SIMPONI was developed by Johnson & Johnson as an anti-TNF biologic targeting TNF-alpha protein involved in inflammation. The company holds exclusive worldwide marketing rights to SIMPONI.
The product carries warnings regarding serious infections such as tuberculosis and histoplasmosis; cancer risks including lymphoma; potential heart failure or nervous system problems; liver complications; blood abnormalities; allergic reactions; as well as considerations related to concurrent drug use or vaccinations.
Patients should discuss any side effects or concerns with their healthcare providers and report adverse events to regulatory authorities such as the FDA.
For more information about SIMPONI visit www.simponi.com.
Johnson & Johnson stated it remains committed to advancing treatments for chronic immune-mediated diseases through ongoing research and innovation.