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FDA Advisory Committee Recommends Approval of REMICADE® for Treatment of Pediatric Ulcerative Colitis
Date:7/21/2011

o severely active UC and voted the benefit:risk profile supports the approval of REMICADE® for pediatric UC indications including induction and maintenance of clinical remission and induction of mucosal healing.  However, the committee did not recommend REMICADE for pediatric UC indications of maintenance of mucosal healing and eliminating corticosteroid use.  Results from the trial were presented in May and showed that treatment with REMICADE® 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.  

GIDAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of gastrointestinal diseases.  The committee provides non-binding recommendations based on its evaluation; the FDA is not bound by the committee's recommendation, but does take its advice into consideration.

About Ulcerative Colitis

Ulcerative colitis (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)  

About REMICADE®

REMICADE® was the first anti-tumor necrosis factor (TNF)-alpha treatment approved in the United States in August 1998 and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  REMICADE® has demonstrated broad clinical utility with indications in Croh
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SOURCE Janssen Biotech, Inc.
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