Approval of Upadacitinib in Pediatric Patients with Active Polyarticular Juvenile Idiopathic Arthritis or Active Psoriatic Arthritis: A Regulatory Perspective

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The FDA approved upadacitinib for treating active polyarticular juvenile idiopathic arthritis in pediatric patients.
Approved dosing includes both a twice daily and a once daily regimen for different formulations.
Clinical development for this indication included a single study on pharmacokinetics, safety, and tolerability.
The findings support efficacy extrapolation in children from adult data due to similar disease pathology.

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FDA approves upadacitinib for active juvenile idiopathic arthritis and psoriatic arthritis, indicating regulatory support for pediatric dosing.

He et al. (2025) studied this question.

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FDA approves upadacitinib for active juvenile idiopathic arthritis and psoriatic arthritis, indicating regulatory support for pediatric dosing.