Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP) 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(R) (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.
Upon receipt of the corresponding Commission Decision, REMICADE will be 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 sufferers, delayed development and stunted growth.
In May 2006, the United States Food and Drug Administration (FDA) approved REMICADE for pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy — establishing REMICADE as the only biologic therapy for this indication in the U.S. REMICADE was first approved in the U.S. for adult Crohn’s disease in 1998 and later for adult ulcerative colitis in 2005.
The safety and efficacy of REMICADE have been well established in clinical trials over the past 14 years and through commercial experience with nearly 840,000 patients treated worldwide across all indications.
The label extension will permit physicians to administer a 5 mg/kg intravenous infusion of REMICADE over a 2-hour period followed by additional 5 mg/kg infusion doses at two and six weeks after the first infusion, then every eight weeks thereafter. Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. Available data do not support further infliximab treatment in pediatric patients not responding within the first 10 weeks of treatment.