FDA seeks panel advice on aptness of adult Remicade data in peds for colitis
This article was originally published in Scrip
Because adult and pediatric ulcerative colitis are sufficiently similar in disease characteristics, US FDA drug reviewers determined that it would be possible to extrapolate efficacy data from Janssen Biotech’s adult ACT 1 and ACT 2 trials of Remicade (infliximab) to children, but said pharmacokinetic data were lacking.
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