Healthcare
SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease
AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. A new 55 mg pre-filled syringe (PFS) has also been approved to support weight-based dosing for patients weighing less than 40 kg, while the currently available 150 mg PFS and Pen are approved
About this update from Abbvie Inc.
NORTH CHICAGO, Ill., June 26, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. A new 55 mg pre-filled syringe (PFS) has also been approved to support weight-based dosing for patients weighing less than 40 kg, while the currently available 150 mg PFS and Pen are approved for patients weighing 40 kg or greater. "Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints – these conditions can shape daily life and disrupt important childhood experiences," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We are proud that SKYRIZI is now the first and only IL-23 inhibitor approved in the U.S. for pediatric patients six years of age and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis. For families navigating these chronic conditions, expanding access to treatments with proven efficacy supports improved disease management and extends established standards of care to younger patients." Approximately 30% of people who develop psoriasis experience symptoms before age eighteen.1 Each year, approximately 20,000 children under ten years old are diagnosed with psoriasis in the U.S., and an estimated 14,000 children are impacted by psoriatic arthritis.1,2,3 Psoriasis and psoriatic arthritis symptoms in children can interfere with mobility and daily activities, with additional burden on caregivers.4,5 "For children impacted by immune-mediated diseases, childhood can become shaped by doctor appointments, uncertainty and the emotional weight of living with a chronic disease," said Leah M. Howard, J.D., president and chief executive officer, National Psoriasis Foundation. "Having an approved treatment for both skin and joint disease available for our younger patients gives families another much-needed option and offers a measure of hope as they navigate the challenges of these diseases."