Centocor and fellow USA-based drugmaker Schering-Plough say that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending the approval of Remicade (infliximab) for the treatment of severe, active Crohn's disease in pediatric patients aged six 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.
The firms noted that, upon receipt of the corresponding Commission decision, Remicade will be the first and only biologic therapy approved in the European Union for the treatment of pediatric Crohn's, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in diarrhea, fever, abdominal pain, weight loss and, sometimes, even delayed development.
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