AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for children aged six and older living with moderate-to-severe plaque psoriasis or active psoriatic arthritis.
This landmark approval introduces a new 55 mg pre-filled syringe specifically designed to support weight-based dosing for pediatric patients weighing less than 40 kg. For children weighing 40 kg or more, the currently available 150 mg pre-filled syringe and pen remain the approved options. With this decision, SKYRIZI becomes the first and only IL-23 inhibitor approved in the United States for pediatric patients in this lower weight bracket.
The expanded approval is backed by robust data from the Phase 3 OptIMMize clinical trial program, which demonstrated significant efficacy, long-term disease management, and a safety profile consistent with adult studies. Because roughly 30% of psoriasis cases begin during childhood, this expansion provides families with a critical, proven therapeutic option to control chronic skin and joint inflammation and minimize disruptions to daily childhood experiences.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
