FDA Approves HUMIRA: New Pediatric Treatment For Crohn's Disease

A new pediatric treatment for Crohn's disease has been approved by the U.S. Food and Drug Administration (FDA). HUMIRA ® is now the only biological drug that's FDA-approved for children six years of age and older when all other inflammatory bowel treatments (IBD) have failed.

"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 of Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center , via IBD News Today. "The approval of HUMIRA for this patient population offers a new important treatment option for physicians and their patients who can help address this sometimes debilitating disease."

Crohn's disease remains one of the most common types of IBD, along with Ulcerative Colitis. The chronic inflammation that affects the small intestine and colon can cause significant damage to the body and is typically diagnosed in adolescents and young adults between the ages of 15-35, though it can also occur in children as young as 7 years old. In the United States at this time, it's estimated that as many as 38,000 children are suffering from Crohn's disease.

The approval was based on data from the Phase III IMAgINE-1 trial that assessed multiple dosing strategies of the drug to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease and was carried out in patients six to 17 years of age.

HUMIRA® inhibitstumor necrosis factor-alpha (TNF-α) - an inflammatory cytokine - and can be self-administered. In Europe, HUMIRA® was already approved as an alternative treatment in pediatric patiens who have failed improving with other conventional treatments.