Health Canada approves risankizumab for children with plaque psoriasis

Health Canada has approved risankizumab (SKYRIZI) for pediatric patients aged 6 to under 18 with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, AbbVie announced on October 20. The pediatric indication is included in the Canadian product information. This does not mean that every child with psoriasis is eligible or that a public drug plan has begun coverage.

What changed

Risankizumab is a prescription biologic. The newly approved population is defined by age, disease severity and the need for treatment beyond topical therapy: the Canadian wording specifies children and adolescents who are candidates for systemic therapy or phototherapy. Decisions about whether a particular young person meets those criteria belong with the treating specialist and family, based on the clinical picture and the current Canadian product monograph.

Evidence and what the announcement does not establish

AbbVie says the decision was supported by OptIMMize-1, a phase 3 study in children and adolescents with moderate-to-severe plaque psoriasis. The company’s release is the source for the approval announcement and its summary of the supporting trial. Pharmacists seeking the exact approved population, dose, administration instructions, contraindications, warnings and monitoring details should use the current Canadian product monograph rather than relying on a press release or a summary from another jurisdiction.

Health Canada authorization and drug-plan coverage are separate steps. The approval establishes that the product may be prescribed for the indicated population under its Canadian terms; provincial and territorial public plans, private insurers and hospital programs determine coverage under their own processes. A formulary listing, prior-authorization criteria or patient-support arrangement should be checked locally before a family makes a financial or treatment decision.

Practice guidance for pharmacists

• When a prescription is presented for a patient under 18, confirm that the current Canadian monograph includes the pediatric plaque-psoriasis indication and that the patient’s age and clinical eligibility align with its wording.
• Verify the prescribed dose and schedule against the current Canadian monograph, including the patient’s weight-based requirements and the exact presentation supplied; do not transfer dosing from an adult regimen or another country’s label.
• Coordinate questions about systemic-therapy or phototherapy candidacy with the dermatologist or pediatric specialist. Avoid treating the new indication as a recommendation to move every child with plaque psoriasis to a biologic.
• Review product-specific handling, administration, precautions and monitoring with the caregiver and young patient using the Canadian monograph and the prescriber’s plan; clarify who to contact if a dose is delayed or an adverse effect is suspected.
• Check public or private coverage criteria separately from the approval, explain any authorization or cost steps before dispensing, and document the source of coverage information shared with the family.

The announcement is a meaningful expansion of a Canadian treatment option for a defined pediatric group. The practical next step for pharmacy teams is to work from the updated Health Canada label, confirm the treatment plan with the prescriber and keep access discussions distinct from regulatory approval.