EU's CHMP recommends approval of Humira (adalimumab) for Crohns disease in paediatric patients- AbbVie

The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for Humira (adalimumab), from AbbVie, for the treatment of moderately to severely active Crohn's disease in pediatric patients (from six years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

The positive opinion is based on the results of the IMAgINE-1 study, the largest multi-center, randomized, open-label induction, followed by double-blind maintenance trial in patients six to 17 years of age with moderately to severely active Crohn's disease to date. Moderately to severely active Crohn's disease was defined by a Pediatric Crohn's Disease Activity Index (PCDAI) more than 30 at baseline.

Humira is currently approved in the European Union for the treatment of severe active Crohn's disease in pediatric patients (from six 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.