Adalimumab (Humira) Gets FDA Nod for Children With Crohn's

Megan Brooks

September 25, 2014

The US Food and Drug Administration (FDA) has approved adalimumab (Humira, AbbVie) for reducing signs and symptoms and for achieving and maintaining clinical remission in children aged 6 years and older with Crohn's disease inadequately controlled with corticosteroids or immunomodulators.

It is the eighth indication for the tumor necrosis factor inhibitor in the United States and the first and only biologic agent approved for use in this patient population that can be administered at home after proper injection training, the company says in a news release.

"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," Jeffrey S. Hyams, MD, head of the Division of Digestive Diseases, Hepatology and Nutrition at Connecticut Children's Medical Center in Hartford, said in the release.

"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," Dr. Hyams said.

An estimated 38,000 children and adolescents in the United States have Crohn's disease. Symptoms of pediatric Crohn's disease mirror those in adults and can include abdominal pain, weight loss, and diarrhea. As in adults, induction and maintenance of clinical remission is one of the treatment goals.

The new indication for adalimumab in pediatric Crohn's disease was based on the multicenter, randomized, double-blind phase 3 Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease (IMAgINE 1) study, published in the August 2012 issue of Gastroenterology.

The study enrolled 192 children aged 6 to 17 years with moderately to severely active Crohn's disease for whom conventional treatment was unsuccessful. The study found that adalimumab can induce and maintain clinical remission in children with Crohn's disease, with a safety profile comparable to that seen in adults with Crohn's disease.

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