AbbVie has announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for HUMIRA® (adalimumab) 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.
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.2
"The positive CHMP opinion represents a significant milestone for the pediatric gastroenterology community as we move closer to European approval of HUMIRA in pediatric patients with moderately to severely active Crohn's disease, a chronic condition with no known cure that affects a growing number of children worldwide," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to the ongoing study and innovation of HUMIRA, and we look forward to expanding this treatment option, once approved, to help more children with this debilitating illness during a vulnerable time in their lives."
"There is no known cure for children and adolescents affected by Crohn's disease, therefore treatment options are important," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "A large-scale investigation such as the IMAgINE trial showcases the safety and efficacy profile of HUMIRA in the moderately to severely active pediatric Crohn's disease population."