AbbVie Announces European Commission Approval of SKYRIZI® for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

• 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 weight-based dosing for patients weighing less than 40 kg¹
• Nearly a third of people living with psoriasis develop symptoms before the age of 18, often getting lesions on highly visible areas^2,3

- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved SKYRIZI® (risankizumab) for the treatment of children and adolescents six years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy. The approval includes a new 55 mg pre-filled syringe (PFS) to support weight-based dosing for patients weighing less than 40 kg.1

"Plaque psoriasis in children carries its own clinical complexity and urgency to provide additional efficacious treatment options," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "Today's approval of SKYRIZI for pediatric psoriasis patients is a meaningful step forward for millions worldwide who are looking for additional treatment options to better manage this chronic disease in their formative years."

Nearly a third of people living with psoriasis develop symptoms before the age of 18, often getting lesions on highly visible areas.^2,3 Because children often have facial or scalp involvement, the early-onset of psoriasis increases the risk of school absenteeism, potential social stigma, and development of other comorbidities.^3,4 Despite the significant impact of the disease on children's quality of life, nearly 70% of pediatric patients rely solely on topical therapies.⁵

Data Supporting the EC Approval

The EC's approval of SKYRIZI in pediatric patients is supported by clinical data from the Phase 3 OptIMMize-1 pediatric psoriasis program (NCT04435600), including data from two lead-in pharmacokinetic cohorts: a randomized efficacy assessor-blinded, active-controlled cohort (12 to <18 years), and a single-arm, open-label cohort (6 to <12 years), in addition to the Phase 3 OptIMMize-2 open-label extension study (NCT04862286). The safety profile in pediatric patients (n=137) treated with SKYRIZI was consistent with that observed in adults with moderate to severe plaque psoriasis, with no new safety signals observed.¹

"Particularly for pediatric psoriasis patients, early diagnosis and management can prevent symptoms from worsening and improve quality of life in the long-term," said Nina Magnolo, M.D., Department of Dermatology, University Hospital of Münster, and lead investigator of the OptIMMize-1 study. "The EC's approval of risankizumab provides younger patients with more options including weight-based dosing and allows physicians to address unmet clinical needs of children living with moderate to severe psoriasis with confidence."

About SKYRIZI^® (risankizumab)
SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. SKYRIZI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis in adults.

EU Indications and Important Safety Information about Skyrizi^® (risankizumab)¹

Indications

Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Important Safety Information

Risankizumab is contraindicated in patients hypersensitive to the active substance or to any of the excipients, and in patients with clinically important active infections (e.g. active tuberculosis).

Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of risankizumab. If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.

The most frequently reported adverse reactions were upper respiratory infections (13% in psoriasis, 15.6% in Crohn's disease and 26.2% in ulcerative colitis).

Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, rash, eczema, fatigue, and injection site reactions.

This is not a complete summary of all safety information.

See Skyrizi full Summary of Product Characteristics (SmPC) at www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information. 

About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.

Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

1. SKYRIZI. Summary of Product Characteristics. AbbVie; 2026.
2. Sticherling M, McPherson T, de Lucas Laguna R, et al. Patient Characteristics and Treatment Patterns in European Pediatric Patients with Psoriasis: A Real-World, Cross-Sectional Study. Dermatol Ther (Heidelb). 2022;12(8):1793-1808. doi:10.1007/s13555-022-00761-7
3. Yang A, Cheng B, Seyger MMB, Murphy R, Stoll ML, Cordoro KM, van de Kerkhof P, Paller AS. The burden of pediatric psoriasis: a systematic review. Am J Clin Dermatol. Published online 2025. doi:10.1007/s40257-025-00965-5
4. Bronckers IM, Paller AS, van Geel MJ, van de Kerkhof PC, Seyger MM. Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities. Paediatr Drugs. 2015;17(5):373-384. doi:10.1007/s40272-015-0137-1
5. Seyger MMB, Augustin M, Sticherling M, et al. Physician-reported Clinical Unmet Needs, Burden and Treatment Patterns of Paediatric Psoriasis Patients: A US and EU Real-world Evidence Study. Acta Derm Venereol. 2022;102:adv00660. Published 2022 Feb 28. doi:10.2340/actadv.v101.981

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