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REMICADE® Receives FDA Approval as First Biologic Treatment for Pediatric Ulcerative Colitis
Date:9/23/2011

174; 5 mg/kg induced clinical response in 73 percent of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.  

"Today's approval of REMICADE® is significant for children and their families who are affected by this devastating disease and are seeking an effective treatment option," said Rob Bazemore, President, Janssen Biotech, Inc.  "We are proud of our heritage in the continued pursuit of expanding treatment options for patients living with immune-mediated inflammatory diseases like IBD."

REMICADE® was designated orphan drug status by the FDA on November 12, 2003, and the supplemental Biologics License Applications (sBLA) for pediatric UC received priority review following its submission to the FDA in December 2010. The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) recommended the approval of REMICADE® in pediatric patients with UC.

On September 1, 2011, Janssen Inc. announced Health Canada approved REMICADE® for the treatment of pediatric patients (age six to 17 years) with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

About the Study

The Phase 3 randomized, multicenter, open-label trial was designed to evaluate the efficacy of a 3-dose REMICADE® regimen in inducing clinical response in pediatric patients with moderately to severely active UC and to evaluate the safety of REMICADE® during induction and maintenance treatment.  A total of 60 patients, aged 6-17, with a median disease duration of 1.4 years were included in the study.  Patients had a median Mayo score of 8.0, and median Pediatric Ulcerative Colitis Activity Index (PUCAI) score of 55.  All pat
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SOURCE Janssen Biotech, Inc.
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