CHICAGO, May 9, 2011 /PRNewswire/ -- 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 (UC), 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 (FDA) 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.
UC is a chronic inflammatory bowel disease (IBD) of the colon. It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease. An estimated 150,000 children under age 17 are living with debilitating symptoms of IBD.(1)
"The results of this study are consistent with findings from the Active Ulcerative Colitis (ACT) trials, which evaluated REMICADE in the treatment of adults with ulcerative colitis," said Jeffrey Hyams, Head of the Division of Digestive Diseases and Nutrition at Connecticut Children's Medical Center and Professor of Pediatrics at University of Connecticut School of Medicine, and lead study investigator. "UC can be a devastating disease, particularly for children and adolescents. It is encouraging to see such promising results in a patient population that is in need of additional treatment options."
In December 2010, Centocor Ortho Biotech Inc. submitted a supplemental Biologics License Application (sBLA) to the FDA requesting the approval of REMICADE (infliximab) for the treatment of modera
|SOURCE Centocor Ortho Biotech Inc.|
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