FDA Approves Humira for the Treatment of Crohn's Disease in Children

The FDA has approved a new indication for adalimumab (Humira) to treat pediatric patients age 6 years and older afflicted with moderately to severely active Crohn's disease.

AbbVie announced today that the FDA has approved a new indication for adalimumab (Humira) to treat pediatric patients age 6 years and older afflicted with moderately to severely active Crohn’s disease who have not responded adequately to prior treatment with corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

This expanded approval makes Humira the first and only at-home biologic treatment approved for use in pediatric patients with Crohn’s disease, a type of inflammatory bowel disease (IBD) characterized by symptoms that include abdominal pain, weight-loss, and diarrhea.

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