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Remicade Gets EU Approval for Pediatric Crohn’s Disease

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Centocor, Inc. and Schering-Plough received approval from the European Commission for a new indication for Remicade for the treatment of severe, active Crohn’s disease (CD) in pediatric patients, aged 6 to 17 years, who have not responded to conventional therapy. Remicade has been studied only in combination with conventional immunosuppressive therapy.

Remicade is the first biologic therapy approved in the EU for the treatment of pediatric CD, a condition that causes inflammation of the gastrointestinal tract, resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and in some patients, delayed development and stunted growth.

In May 2006, the FDA approved Remicade for pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy. Remicade was first approved in the U.S. for adult Crohn’s disease in 1998 and in 2005 for adult ulcerative colitis.

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