CHMP recommends Humira (Abbott) for paediatric patients with Crohn's Disease - 21-Oct-2012

The CHMP has adopted a positive opinion for Humira (adalimumab), from Abbott Labs, for the treatment of paediatric patients aged six to 17 years with severely active Crohn's Disease (CD) who failed, are intolerant to or have contraindications to conventional therapy. Following the CHMP's positive opinion, a final decision from the European Commission is anticipated in the next few months. If approved Humira will be the only biologic in the EU for the treatment of paediatric CD offering at-home administration.

Upon final approval, Humira will be indicated for the treatment of severe active Crohn's Disease in paediatric patients (6 to 17 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies. The filing was supported by a Phase III dosing study, the IMAgINE 1 trial, which evaluated weight-based dosing strategies of Humira to induce and maintain clinical remission in pediatric patients with moderately to severely active CD.