AbbVie (ABBV) announced that the European Commission has approved SKYRIZI for children and adolescents six years of age and older with moderate to severe plaque psoriasis, expanding the therapy's use beyond adults and marking a significant regulatory milestone for the company.
Burden of Pediatric Psoriasis
Plaque psoriasis is a chronic inflammatory skin disease that often begins in childhood, with nearly one-third of patients developing symptoms before age 18. These young patients frequently experience lesions on visible areas such as the face and scalp, contributing to school absenteeism, social stigma, and increased risk of other health complications. Despite this burden, nearly 70% of pediatric patients rely solely on topical therapies, underscoring the need for additional systemic treatment options.
Details of the EC Approval
SKYRIZI, an IL-23 inhibitor, will now be available to pediatric patients who are candidates for systemic therapy. The approval also introduces a new 55 mg pre-filled syringe designed for weight-based dosing in children weighing less than 40 kg.
Clinical Data Supporting the Decision
AbbVie said the decision was supported by data from the Phase 3 OptIMMize-1 and OptIMMize-2 clinical program, which included randomized and open-label cohorts evaluating safety, pharmacokinetic, and efficacy in patients aged 6 to 17. The safety profile in pediatric patients was consistent with that observed in adults, with no new safety signals identified.
Roopal Thakkar, M.D., AbbVie's chief scientific officer, said the approval represents an important advancement for young patients living with psoriasis, noting the clinical complexity of treating the disease in children and the need for effective systemic options.
The company emphasized that the expanded indication reinforces its commitment to addressing unmet needs across immune-mediated diseases.
U.S Approval History and Market Performance
SKYRIZI was first approved in the United States on April 23, 2019, for adults with moderate to severe plaque psoriasis, marking its initial regulatory clearance before expanding into multiple immune-mediated indications.
AbbVie reported that SKYRIZI generated $4.483 billion in global revenue in Q1 2026, an increase from $3.425 billion in Q1 2025, reflecting continued strong demand and growth across approved indications.
Upcoming FDA Decision
The company is also pursuing SKYRIZI in additional indications. AbbVie recently submitted an application to the U.S. FDA seeking approval for subcutaneous (SC) induction in adult patients with moderately to severely active Crohn's disease. The submission is supported by data from the Phase 3 AFFIRM study. AbbVie expects an FDA decision later this year.
ABBV has traded between $181.73 and $244.81 over the past year. The stock closed Monday's trading at $230.01, up 6.25%.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.