AbbVie SKYRIZI (risankizumab-rzaa) FDA approved for pediatric psoriatic disease

FDA approved SKYRIZI for children 6 years and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis, including a new 55 mg pre-filled syringe for weight-based dosing in patients <40 kg. SKYRIZI is now the first and only IL-23 inhibitor approved in the U.S. for this pediatric population.

Key facts

Filed: Jun 26, 2026, 08:50 PM
Event: FDA approval
Direction: Positive
Company: ABBVAbbVie
Asset: risankizumab
Source: Company press release
Confidence: Sourced

Source excerpt

SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease News provided by AbbVie Jun 26, 2026, 16:50 ET Share this article Share to X Share this article Share to X SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis Approval includes a new 55 mg pre-filled syringe to support weight-based dosing for those patients weighing less than 40 kg SKYRIZI becomes 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 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

Company press release