OTTAWA (dpa-AFX) - Drugmaker AbbVie Inc. (ABBV) announced Tuesday that Health Canada has approved SKYRIZI (risankizumab) to treat children with moderate to severe plaque psoriasis.
The treatment will be given for pediatric patients aged 6 to <18 years of age with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Separately, AbbVie announced a multi-year partnership with McLaren Racing to become an Official Pharmaceutical Partner of the McLaren Mastercard Formula 1 Team.
Regarding the Health Canada Approval, the company noted that Psoriasis is a chronic inflammatory disease that can begin during childhood or adolescence. In the patients, nearly one-third develop symptoms before age 18.
SKYRIZI is a humanized monoclonal antibody that selectively inhibits interleukin-23 (IL-23), a key cytokine involved in inflammatory processes.
The Health Canada approval is supported by OptIMMize-1, a Phase 3 study of children and adolescents with moderate to severe plaque psoriasis.
In the trial, 79.6% of SKYRIZI-treated patients aged 12 to <18 years of age had clear or almost clear skin at Week 16, while 85.2% experienced at least a 75% improvement in the extent and severity of their psoriasis.
Among children aged 6 to <12 years of age, 90.0% had clear or almost clear skin and 86.7% experienced at least a 75% improvement.
For children and adolescents, dosing is based on body weight, with treatment given initially, again four weeks later and every 12 weeks thereafter.
As per the trial, the safety profile of SKYRIZI in pediatric patients was generally consistent with that observed in adults with plaque psoriasis.
According to the company, the approval expands treatment options for eligible children and adolescents living with the chronic inflammatory disease, which can affect much more than the skin.
Marissa Joseph, Medical Director, RKS Dermatology Centre, Women's College Hospital, and AbbVie Chair in Ethnodermatology, University of Toronto, stated, 'Psoriasis can have a significant physical and emotional impact on children and adolescents, particularly when symptoms are visible or interfere with everyday life. Pediatric psoriasis requires an individualized approach that considers a young person's age, disease severity and treatment needs. Having another approved treatment option gives physicians greater flexibility when considering care for children and their families.'
SKYRIZI is approved in Canada for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SKYRIZI is indicated for the treatment of adults with moderately to severely active Crohn's disease as well as moderately to severely active ulcerative colitis.
In pre-market activity on the NYSE, the shares were trading at $284.00, up 0.47 percent.
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