The European Commission has approved Skyrizi (risankizumab) for children and adolescents aged six years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy, extending AbbVie’s (NYSE: ABBV) IL-23 inhibitor into a pediatric population that has historically had limited biologic options. Although the pediatric population is substantially smaller than the adult market, early biologic intervention is increasingly accepted in severe disease.
The approval includes a new 55 mg pre-filled syringe formulation to support weight-based dosing in patients weighing less than 40 kg, an important practical consideration given the variability in body weight across the six-and-older age range. Risankizumab selectively inhibits IL-23 by binding to its p19 subunit, blocking a cytokine central to the inflammatory cascade underlying plaque psoriasis. The existing adult dosing regimen of 150 mg is not appropriate across all pediatric weight categories, making the new formulation a necessary component of the approval rather than an incremental addition.
The clinical package supporting the EC decision drew on the Phase III OptIMMize-1 program (NCT04435600) and a lead-in pharmacokinetic cohort (NCT04862286). Among 137 pediatric patients treated with risankizumab, the safety profile was reported as consistent with that observed in adults, with no new safety signals identified. Efficacy data from the randomized, assessor-blinded, active-controlled cohort provided the primary basis for the indication, though full endpoint data were not disclosed in the announcement.
The pediatric psoriasis approval further expands Skyrizi’s label as AbbVie continues to position the IL-23 inhibitor as a cornerstone immunology franchise. The drug is already approved for plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and other inflammatory conditions, and has become one of AbbVie’s fastest-growing products following the loss of exclusivity of Humira.a