FDA approves Humira for Crohns in patients 6 years and older - AbbVie

The FDA has approved Humira (adalimumab), from AbbVie, for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's Disease patients 6 years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for Humira in the United States and makes it the first and only biologic treatment approved for use in this patient population that can be administered at home.

The FDA approval was supported by the Phase III IMAgINE-1 trial, which evaluated multiple dosing strategies of Humira to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease for whom certain other treatments have not worked well enough. IMAgINE-1 is the largest multi-center, randomized, double-blind anti-TNF trial in patients 6 to 17 years of age with moderately to severely active Crohn's disease conducted to date.