Abbott's HUMIRA (Adalimumab) Approved in Europe for Severe Active Pediatric Crohn's Disease
Abbott announced that the European Commission has approved HUMIRA® (adalimumab) for the treatment of pediatric patients aged 6 to 17 years with severe active Crohn's disease (CD) who failed, are intolerant to, or have contraindications to conventional therapy. With this approval, Humira becomes the first biologic treatment approved for these patients in more than five years.
"Crohn's disease can be particularly difficult in the pediatric population not only because of the disruptive nature of the disease, but also because these patients are in a key physical and social development stage of their lives," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "This approval gives physicians and patients an important new option to consider for the treatment of this chronic and debilitating disease."
The approval was supported by the Phase 3 IMAgINE 1 trial, which evaluated two different dosing strategies of HUMIRA to induce and maintain clinical remission in pediatric patients with severe active CD.
"The availability of HUMIRA for this patient population addresses an unmet need throughout the European Union and reinforces Abbott's long-standing commitment to patients with inflammatory bowel disease," said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott. "With this approval, these young patients and their care providers may now have access to a therapy that can help manage their disease and be administered at home."
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