Remicade Gains Indication for Pediatric Ulcerative Colitis

Janssen Biotech announced that the FDA has approved Remicade (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. This approval was based on data from a Phase 3, randomized, multicenter, open-label trial designed to evaluate the efficacy of a 3-dose Remicade regimen in inducing clinical response in 60 pediatric patients aged 6–17 years with moderately to severely active UC. The study showed that treatment with Remicade induced clinical response in 73% of patients at Week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.  

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