FDA Greenlights Skyrizi for Pediatric Patients
The U.S. Food and Drug Administration has approved risankizumab-rzaa (Skyrizi) to treat pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy or active psoriatic arthritis. The regulatory clearance was announced by manufacturer AbbVie.
Broadening the Reach of IL-23 Inhibition
Risankizumab-rzaa is the first and only IL-23 inhibitor approved in the U.S. for pediatric patients aged at least 6 years weighing less than 40 kg with plaque psoriasis or psoriatic arthritis, according to Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer at AbbVie.
“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, MD, executive vice president, research and development, chief scientific officer at AbbVie. “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.”
Tailored Dosing for Smaller Patients
To facilitate treatment for younger children, the FDA authorized a new 55 mg prefilled syringe. This adjustment allows for weight-based dosing for patients weighing less than 40 kg. For those weighing at least 40 kg, the 150 mg prefilled syringe and pen are approved.
Safety and Clinical Trial Performance
The approval relies on data gathered during the phase 3 OptIMMize psoriasis clinical trial program. AbbVie reports that the safety profiles of pediatric patients with plaque psoriasis were comparable with the safety profiles of adult patients with plaque psoriasis treated with risankizumab-rzaa.
Clinical data identified several common adverse events associated with the medication:
- Upper respiratory infections
- Headache
- Feeling tired
- Injection site reactions
- Fungal skin infections
Addressing Chronic Inflammatory Conditions
Plaque psoriasis manifests as raised, scaly skin patches, while psoriatic arthritis acts as a related inflammatory condition affecting both joints and skin. Because both are chronic, immune-mediated diseases, they require long-term management strategies. The introduction of systemic therapies like IL-23 inhibitors offers clinicians targeted tools to address underlying inflammatory pathways. Patients and caregivers should consult with a pediatric rheumatologist or dermatologist to determine if systemic therapy is appropriate based on the severity of the child’s symptoms and their response to previous treatments.