The approval is based on safety and efficacy results from a clinical study of JIA patients four to 17 years of age. According to the company, JIA is the sixth disease indication for which Humira has received approval since 2002.
Eugene Sun, vice president, global pharmaceutical clinical development of Abbott, said: “The approval of Humira provides an excellent option in the treatment of JIA. In addition to its efficacy in reducing the signs and symptoms of polyarticular JIA, we believe that children and their caretakers will appreciate the benefit of convenient every-other-week dosing that Humira offers.”