The European Commission approves SKYRIZI (risankizumab) for pediatric patients aged six years and older with moderate to severe plaque psoriasis, AbbVie says. The approval expands the medicine’s indication to children and adolescents who meet the defined criteria for plaque psoriasis severity. AbbVie states the decision is based on results from the pivotal Phase 3 OptIMMize-1 and OptIMMize-2 trials. The company also notes that the expanded pediatric use is supported by a new 55 mg pre-filled syringe, designed for administering risankizumab in this population. Across the provided information, the reported action is the European Commission’s authorization of the new pediatric indication, and the evidence cited comes from the two named Phase 3 studies. The sources emphasize that the change specifically covers pediatric patients six years of age and older with moderate to severe plaque psoriasis, reflecting an expansion from prior approved age groups.
European Commission approves AbbVie’s SKYRIZI for pediatric moderate-to-severe plaque psoriasis
The European Commission approves SKYRIZI (risankizumab) for pediatric patients aged six years and older with moderate to severe plaque psoriasis, AbbVie says. The approval expands the medicine’s indic...
- The European Commission approves SKYRIZI (risankizumab) for pediatric plaque psoriasis.
- The approved age group is children and adolescents aged 6 years and older.
- The indication is for moderate to severe plaque psoriasis.
- AbbVie says the approval is based on Phase 3 OptIMMize-1 and OptIMMize-2 trial results.
- AbbVie reports a new 55 mg pre-filled syringe supports pediatric dosing.
SKYRIZI® (risankizumab) expands its indication for children and adolescents six years of age and older with moderate to severe plaque psoriasis1 Approval was based on the pivotal Phase 3 OptIMMize-1 and OptIMMize-2 trials which include a new 55 mg pre-filled syringe to support...
9 hours agoSKYRIZI® (risankizumab) expands its indication for children and adolescents six years of age and older with moderate to severe plaque psoriasis1 Approval was based on the pivotal Phase 3 OptIMMize-1 and OptIMMize-2 trials which include a new 55 mg pre-filled syringe to support...
9 hours ago
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