American pharmaceutical company AbbVie (NYSE: ABBV) on Tuesday said Health Canada has approved SKYRIZI (risankizumab) for patients aged six to under 18 with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The approval was supported by the Phase 3 OptIMMize-1 study in patients aged six to under 18. At week 16, 79.6% of SKYRIZI-treated patients aged 12 to under 18 had clear or almost clear skin and 85.2% achieved at least a 75% improvement in disease severity.
Among children aged six to under 12, 90.0% had clear or almost clear skin and 86.7% achieved at least a 75% improvement. The safety profile in paediatric patients was generally consistent with that observed in adults with plaque psoriasis.
For paediatric patients, dosing is based on body weight, with treatment administered initially, again after four weeks and then every 12 weeks. SKYRIZI is also approved in Canada for adults with moderate to severe plaque psoriasis, Crohn's disease and ulcerative colitis in specified treatment settings.
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