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news.Janssen Biotech has obtained the US Food and Drug Administration (FDA) approval for Remicade (infliximab) as a treatment for moderately to severely active ulcerative colitis (UC) in pediatric patients.
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The FDA approval is based on the results of different studies evaluating Remicade in adults with ulcerative colitis plus additional data from a Phase 3 trial investigating the efficacy and safety of Remicade in the treatment of pediatric patients with moderately to severely active UC.
The Phase 3 trial was a randomized, multicenter, open-label trial and was designed to evaluate the efficacy of a 3-dose Remicade regimen inducing clinical response in pediatric patients with moderately to severely active UC.
The treatment with Remicade 5mg/kg induced clinical response in 73% of patients at week 8 and showed a safety profile consistent with previous clinical trials conducted in an adult population.