The European Commission has approved Abbott's HUMIRA® (adalimumab) for the treatment of pediatric patients aged 6 to 17 years with severe active Crohn's disease (CD) who failed, are intolerant to, or have contraindications to conventional therapy.
is a chronic, debilitating condition of the gastrointestinal (GI) tract that affects up to 200,000 children worldwide.
is a type of inflammatory bowel disease and most commonly involves the end of the small intestine and the beginning of the large intestine. In addition to symptoms such as abdominal pain, weight loss and diarrhea, pediatric
can affect children in several ways unique to this age group, including delayed growth and/or puberty.
"Crohn's disease can be particularly difficult in the pediatric population not only because of the disruptive nature of the disease, but also because these patients are in a key physical and social development stage of their lives," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "This approval gives physicians and patients an important new option to consider for the treatment of this chronic and debilitating disease."
The approval was supported by the Phase 3 IMAgINE 1 trial, which evaluated two different dosing strategies of HUMIRA to induce and maintain clinical remission in pediatric patients with severe active CD.
"The availability of HUMIRA for this patient population addresses an unmet need throughout the European Union and reinforces Abbott's long-standing commitment to patients with inflammatory bowel disease," said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott. "With this approval, these young patients and their care providers may now have access to a therapy that can help manage their disease and be administered at home."
HUMIRA is indicated for the treatment of severe active Crohn's disease in pediatric 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. It is a TNF blocker medicine given by injection under the skin.