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FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease

NORTH CHICAGO, Ill., Sept. 25, 2014 /PRNewswire/ -- AbbVie announced today that the U.S. Food and Drug Administration (FDA) has approved Humira (adalimumab) 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.1 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.2 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.2 Additionally, when Crohn's disease is diagnosed in childhood, it may be more extensive than when it is diagnosed in adulthood.4 Since there is no known cure for Crohn's disease, one of the treatment goals of pediatric Crohn's disease is to induce and maintain clinical remission.5,6

"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," said Michael Severino, M.D., executive vice president, Research and Development and chief scientific officer, AbbVie. "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."

Humira works by inhibiting tumor necrosis factor-alpha (TNF-α) and can be self-administered after proper injection training is received and with appropriate physician monitoring.

In 2012, the European Commission approved Humira for the treatment of pediatric patients 6 to 17 years of age with severe active Crohn's disease who failed, are intolerant to, or have contraindications to conventional therapy.7

About IMAgINE-1

The FDA approval was supported by the Phase 3 IMAgINE-1 trial, which evaluated multiple dosing strategies of HUMIRA to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease for whom certain other treatments have not worked well enough. IMAgINE-1 is the largest multi-center, randomized, double-blind anti-TNF trial in patients 6 to 17 years of age with moderately to severely active Crohn's disease conducted to date.8

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com.

  1. Rabizadeh S, Hyams JS, Dubinsky M. Crohn's disease. In: Wyllie R, Hyams JS, Kay M, eds. Pediatric Gastrointestinal and Liver Disease. 4th ed. Philadelphia, PA: Elsevier Saunders; 2011:472-489.
  2. What is Crohn's disease? Crohn's and Colitis Foundation of America website. http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease. Accessed Sept. 16, 2014.
  3. Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured U.S. population. Dig Dis Sci. 2013;58:519–525.
  4. Grossman AB, Baldassano RN. Inflammatory bowel disease. In: Kliegman RM, Stanton BF, Schor NF, St. Geme III JW, Behrman RE. Nelson Textbook of Pediatrics. 19th ed. Philadelphia, PA: Elsevier Saunders; 2011:1294-1304.
  5. Escher JC, Taminiau JA, Nieuwenhuis EE, Buller HA, Grand RJ. Treatment of inflammatory bowel disease in childhood: best available evidence. Inflamm Bowel Dis. 2003; 9(1):34-58.
  6. Rufo PA, Denson LA, Sylvester FA, et al. Health supervision in the management of children and adolescents with IBD: NASPGHAN recommendations. J Pediatr Gastroenterol Nutr. 2012;55(1):93-108.
  7. Humira [Summary of Product Characteristics], Maidenhead, United Kingdom; AbbVie. September 2014.
  8. Hyams J, Griffiths A, Markowitz J, et al. Safety and Efficacy of Adalimumab for Moderate to Severe Crohn's Disease in Children. Gastroenterology. 2012;143:365–374.

SOURCE AbbVie

Posted: September 2014

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