FDA Approves Humira for Pediatric Crohn’s Disease

FDA Approves Humira for Pediatric Crohn’s Disease

humira for pediatric crohn's diseaseAbbvie reported today that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) as a new treatment for Crohn’s disease in children over six years of age, when other treatments have failed. HUMIRA® is the only biological drug to be approved by FDA to treat young patients with pediatric Crohn’s disease.

Jeffrey S. Hyams, M.D., head of Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children’s Medical Center, commented, “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. 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 is one of the most common types (together with Ulcerative Colitis) of inflammatory bowel disease (IBD). It is a chronic inflammation that usually affects the small intestine and colon. Most frequently diagnosed in adolescents and young adults (15-35 years old), it can occur in children as young as 7 years old. In the United States alone, 38,000 pediatric patients, both children and adolescents, are estimated to suffer from Crohn’s disease.

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.

Michael Severino, M.D., executive vice president, Research and Development and chief scientific officer, AbbVie noted, “Children living with moderate to severe Crohn’s disease have limited treatment options, and AbbVie is pleased that HUMIRA will now be an available option for many of these patients. This approval underscores our continued commitment to innovate with HUMIRA, both in studying potential new indications to help meet unmet medical needs and in helping to improve the standard of care for patients living with immune-mediated inflammatory diseases like Crohn’s disease.”