It was recently announced that Remicade was recommended by the Committee for Medicinal Products for Human Use (CHMP) for use in Europe in treating severe active Crohn's disease in kids aged 6 to 17. That'll make Remicade the first therapy approved in the EU for pediatric CD. This was something the FDA has already done in the US back in May 2006.
Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending the approval of REMICADE® (infliximab) 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 in Crohn's disease.
Link to European Union CHMP Recommends Approval Of First And Only Biologic Treatment For Pediatric Crohn's Disease: REMICADE®