The U.S. Food and Drug Administration (FDA) approved the anti-TNF biologic SIMPONI® (golimumab) for the treatment of children weighing at least 15 kg who have moderately to severely active ulcerative colitis (UC), according to an announcement by Johnson & Johnson. This decision significantly expands the therapeutic options available for this complex, chronic condition in the pediatric population.. This decision significantly expands the therapeutic options available for this complex, chronic condition in the pediatric population.

This approval is supported by the PURSUIT program, which included two multi-center, open-label studies demonstrating SIMPONI’s efficacy, safety, and pharmacokinetics. Specifically, data from the pivotal Phase 3 PURSUIT 2 study showed robust early induction results: at Week 6, 32% of patients achieved the primary endpoint of clinical remission, 58% achieved a clinical response, and 40% achieved endoscopic improvement, with 57% of Week 6 remitters maintaining clinical remission through Week 54. The safety profile for these pediatric patients was consistent with that observed in clinical trials involving adults with UC, for whom SIMPONI is already approved for UC, rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).

SIMPONI is administered subcutaneously via a pre-filled syringe and can be self-administered by patients aged 12 years and older after training, with dosing determined by weight: patients ≥40 kg receive 200 mg at Week 0, then 100 mg at Weeks 2, 6, and every four weeks thereafter, while those 15 kg to <40 kg receive half those doses (100 mg at Week 0, then 50 mg at Weeks 2, 6, and every four weeks). This new pediatric indication represents a critical milestone for patients, as approximately 20% of the over one million Americans living with UC are children.