European Union CHMP Recommends Approval Of First And Only Biologic Treatment For Pediatric Crohn’s Disease: REMICADE®
First Positive Opinion Recommending Approval of Biologic Treatment for Severe, Active Crohn’s Disease in Pediatric Patients
Horsham, PA and Kenilworth, NJ (March 26, 2007) – 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.
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.
“The CHMP recommendation for infliximab is an important milestone in addressing an unmet need in treating pediatric patients with Crohn’s disease,” said Peter Milla, M.D., Professor of Paediatric Gastroenterology and Nutrition, Institute of Child Health and Great Ormond Street Hospital for Children, United Kingdom. “Children with Crohn’s disease who do not respond sufficiently to standard treatments have a greatly reduced quality of life. For example, they run a greater risk of growth retardation and osteoporosis by adolescence and may undergo multiple surgical procedures involving the removal of sections of the small and large intestine.”
“This positive opinion is significant for REMICADE® as it will be the first biologic therapy available to children suffering with Crohn’s disease in the EU,” said Robert J. Spiegel, M.D., chief medical officer, Schering-Plough Research Institute. “One cannot stress enough the negative impact of the disease on these children, so there is a great medical need for new and effective treatments. This further validates the utility of REMICADE® as an important treatment in inflammatory bowel disease, which currently is approved in Crohn’s disease and ulcerative colitis in adults.”
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