FDA Approves Risankizumab (Skyrizi) for Pediatric Plaque Psoriasis and Psoriatic Arthritis
The U.S. Food and Drug Administration has expanded the approved indications for Skyrizi to include the treatment of pediatric patients aged 6 years and older with plaque psoriasis and psoriatic arthritis. The expanded approval, announced by AbbVie, extends the use of risankizumab beyond adults, providing a new treatment option for children affected by psoriatic disease. This decision broadens access to biologic therapy for younger patients with these chronic inflammatory conditions.
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."
Data Supporting SKYRIZI Pediatric Approvals
The pediatric psoriasis approval is supported by data from the Phase 3 OptIMMize psoriasis clinical trial program (NCT04435600; NCT04862286), including data from two lead-in pharmacokinetic cohorts, a randomized efficacy assessor-blinded active controlled cohort (12 to <18 years) and a single arm open label cohort (6 to <12 years). The pediatric psoriatic arthritis approval is supported by the OptIMMize psoriasis clinical trial program as well as population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies.
The safety profile observed in pediatric plaque psoriasis patients treated with SKYRIZI was consistent with the established safety profile of SKYRIZI in adult patients with plaque psoriasis.
"At Week 16 in part 2 of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment," said Amy S. Paller, M.D., chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and study investigator in the OptIMMize program. "These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with plaque psoriasis or psoriatic arthritis."
