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news.Centocor's supplemental biologics license application for Remicade for the treatment of pediatric Crohn's disease has been accepted and designated for priority review by the FDA.
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Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn’s disease in patients who have had an inadequate response to conventional therapies.
Currently, there are no approved biologic therapies for the treatment of pediatric Crohn’s disease, a chronic, potentially debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. Children with Crohn’s disease may also experience delayed development and stunted growth.
Orphan drug designation was granted by the FDA to Remicade for the treatment of pediatric Crohn’s disease in November 2003.
“Remicade, if approved for the treatment of pediatric Crohn’s disease, would represent a major advancement for children with this serious condition. We look forward to working closely with the FDA as it reviews these data for approval,” said Dr Jerome Boscia, senior vice president of clinical R&D at Centocor.