HORSHAM, Pa. and KENILWORTH, N.J., Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission has approved a new indication for REMICADE(R) (infliximab) allowing 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 including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies.
REMICADE has been studied only in combination with conventional immunosuppressive therapy. This approval follows a positive opinion granted in March by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMEA).
"Crohn's disease significantly impacts the quality of life of children suffering from this condition," said Salvatore Cucchiara, M.D., Department of Pediatrics, Gastrointestinal Motility and Endoscopy Unit, University of Naples. "Infliximab provides physicians with a new treatment option that addresses the unique aspects of this difficult-to-treat disease in the pediatric population."
REMICADE is the first and only biologic therapy approved in the EU for the treatment of pediatric CD, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and in some patients, delayed development and stunted growth.
"This approval recognizes the unique value of REMICADE as it is the first and only biologic therapy available to children suffering with Crohn's disease in Europe, who previously had limited therapy options," said Robert J. Spiegel, M.D., chief medical officer, Schering-Plough Research Institute.
In May 2006, the United States Food and Drug Administration (FDA) approved REMICADE for pediatric patients with moderately to severely active CD who have hadPage: 1 2 Related medicine news :1
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