J&J JNJ unit says remicade phase 3 is effective.Data from a Phase 3 randomized, multicenter, open-label study demonstrated clinical response with REMICADE® (infliximab) in the treatment of pediatric patients with moderately to severely active ulcerative colitis, and showed a safety profile consistent with previous clinical trials conducted in an adult population. The pediatric UC findings, presented today at Digestive Disease Week, showed REMICADE induced clinical response in 73 percent of patients aged 6-17 years at week 8, the primary endpoint of the trial. REMICADE received U.S. Food and Drug Administration approval for the treatment of adults with moderately to severely active UC in September 2005 and in October 2006, REMICADE received FDA approval for maintaining clinical remission and mucosal healing indications in adults living with UC.
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