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FDA panel weighs Remicade for pediatric UC

July 22, 2011 12:49 AM UTC

FDA's Gastrointestinal Drugs Advisory Committee on Thursday backed approval of Remicade infliximab for three of the five claims for pediatric ulcerative colitis proposed by Johnson & Johnson (NYSE:JNJ). The panel unanimously supported approval for induction of clinical remission and mucosal healing and voted 10-3, with one abstention, in favor of approval for maintenance of clinical remission. The committee voted 8-5, with one abstention, against approval for maintenance of mucosal healing and 12-2 against approval for eliminating corticosteroid use.

The panel indicated that more endoscopy data was necessary to support the maintenance of mucosal healing claim. In J&J's 60-patient, open-label pediatric trial, endoscopy at week 54 was optional, and data was available for only nine patients. The committee voted 10-3, with two abstentions, that extrapolating adult data for corticosteroid use was not appropriate for the pediatric indication. To support such a claim, J&J would need to conduct a well-controlled trial powered for efficacy. J&J's trial, which was not powered for efficacy, took three years to enroll. ...