European Commission Expands Skyrizi Label to Younger Patients
AbbVie (NYSE:ABBV) has received approval from the European Commission to use Skyrizi (risankizumab) in children and adolescents aged six years and older with moderate-to-severe plaque psoriasis who are eligible for systemic treatment.
The authorization broadens the medicine’s reach within Europe and provides a new treatment option for younger patients living with the chronic inflammatory skin condition.
New Formulation Supports Weight-Based Dosing
As part of the approval, regulators also cleared a new 55 mg pre-filled syringe designed to facilitate weight-based dosing for patients weighing less than 40 kilograms.
The additional formulation is intended to support more precise treatment administration across the pediatric population.
Phase 3 Studies Underpin Approval
The decision was supported by results from AbbVie’s Phase 3 OptIMMize-1 pediatric psoriasis trial, along with data from the Phase 3 OptIMMize-2 open-label extension study.
Across both programmes, 137 pediatric patients received treatment with Skyrizi.
AbbVie reported that the therapy demonstrated a safety profile consistent with previous findings in adult patients, with no new safety concerns identified during the studies.
Significant Unmet Need in Younger Patients
Research referenced by the company indicates that psoriasis frequently develops early in life, with nearly one-third of patients experiencing symptoms before reaching adulthood.
The company also noted that approximately 70% of pediatric psoriasis patients currently depend exclusively on topical therapies, highlighting the need for additional treatment options for more severe cases.
Expanding the Reach of an Established Therapy
Skyrizi is an interleukin-23 (IL-23) inhibitor that works by selectively targeting the p19 subunit of IL-23, a cytokine involved in inflammatory processes.
The therapy is already approved in Europe for several adult indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
The latest approval further expands Skyrizi’s potential patient population and strengthens AbbVie’s immunology portfolio within the European market.