FDA Approves Treatment for Active Polyarticular Juvenile Idiopathic Arthritis

Officials with the FDA announced the approval subcutaneous formulation of tocilizumab (Actemra) for treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.

The approval is backed by data from the JIGSAW-117 study, a 52-week phase 1b pharmacokinetic/pharmacodynamic bridging study that was designed to determine the appropriate dosing regimen of Actemra subcutaneous across an array of body weights in children with PJIA.

“Polyarticular juvenile idiopathic arthritis is a rare, often painful disease in children,” Sandra Horning, MD, chief medical officer, head of global product development, Genentech, said in a statement.

“With this approval, we are pleased Actemra offers an alternative delivery option to physicians and parents of children aged 2 or older to treat this debilitating disease.”

The study enrolled 52 patients aged 1—17 years old with PJIA who experienced previous inadequate response or intolerance to methotrexate and were either Actemra naïve or received Actemra IV with adequate disease control.

The treatment was administered open label based on a body weight dosing regimen: PJIA patients weighing <30 kg received 162 mg of Actemra every 3 weeks and PJIA patients weighing ≥30 kg received 162 mg every 2 weeks for 52 weeks.

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