- AbbVie’s Skyrizi (risankizumab) has received Health Canada approval for children and adolescents aged 6 to under 18 with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- The approval is supported by the Phase III OptIMMize-1 study. At Week 16, 79.6% of patients aged 12 to under 18 achieved clear or almost clear skin, compared with 90.0% of children aged 6 to under 12.
- At least 75% improvement in psoriasis severity was achieved by 85.2% of adolescents and 86.7% of younger children. The safety profile in pediatric patients was generally consistent with that observed in adults.
- Treatment is weight-based, with doses administered initially, four weeks later and every 12 weeks thereafter. The approval expands options for young Canadians living with psoriasis, which can affect physical, emotional and social well-being.
Takeaways:
Skyrizi’s pediatric approval expands AbbVie’s reach in plaque psoriasis by extending its IL-23 inhibitor franchise to children and adolescents in Canada. High rates of skin clearance and convenient 12-week maintenance dosing could support competition with established biologics, including Novartis’ Cosentyx and Eli Lilly’s Taltz. Long-term pediatric safety and reimbursement will influence uptake.
Source: CA Newswire
