FDA approves AbbVie's Humira for pediactric Crohn's

North Chicgo-based AbbVie announced today that the U.S. Food and Drug Administration has approved HUMIRA 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.

"Moderate to severe Crohn's disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "The approval of HUMIRA for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease."

Crohn's disease is a type of inflammatory bowel disease (IBD) which commonly involves the end of the small intestine and the large intestine. Crohn's disease can appear at any age, but it is most often diagnosed in adolescents and young adults between 15 and 35 years of age.

In the United States, there are an estimated 38,000 children and teens with Crohn's disease.3 Symptoms of pediatric Crohn's disease are similar to those in adults and can include abdominal pain, weight-loss and diarrhea.