Crohn Disease

U.S. FDA grants priority review of REMICADE for treatment of pediatric Crohn disease

Published in Gene Therapy Weekly, May 4th, 2006

Centocor, Inc. announced that the supplemental Biologics License Application (sBLA) for REMICADE (infliximab) for the treatment of pediatric Crohn disease has been accepted and designated for priority review by the U.S. Food and Drug Administration (FDA).

Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn 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 disease, a chronic, potentially debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as...

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Source: Gene Therapy Weekly (2006-05-04)

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