The FDA has approved the use of Humira as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis or JIA in patients four years of age and older.
Humira is the first biologic treatment to receive FDA approval for this condition since 1999, the company noted. Patients will receive injections once every two weeks.
The FDA approval is based on the results of a 48-week study and a subsequent open-label extension evaluating the efficacy and safety of Humira. In the study, fewer children treated with Humira experienced disease flare compared to placebo. Overall, children on Humira experienced improvements in their disease symptoms.
JIA is the sixth disease indication for which Humira has received approval since 2002. This medicine is already approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and for the treatment of moderate to severe chronic psoriasis.
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