FDA panel weighs Remicade for pediatric UC
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. ...