NORTH CHICAGO, Ill., June 23, 2026 /PRNewswire/ -- 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
Global Media: Mary Byun U.S. Media: Carleigh Kmetz | Investors: Liz Shea |
Im Insolvenzkomplex rund um den einstigen Signa-Konzern steht Firmengründer René Benko vor einem weiteren Strafverfahren. Die österreichische Wirtschafts- und Korruptionsstaatsanwaltschaft (WKStA) hat beim Landesgericht Innsbruck erneut Anklage wegen schweren Betrugs und Schädigung von Gläubigerinteressen (betrügerischer Krida) eingebracht. Der 49‑jährige Investor befindet sich seit Januar 2025 in Untersuchungshaft. Die neue Anklage ist nicht rechtskräftig, es gilt die Unschuldsvermutung, Benko bestreitet sämtliche Vorwürfe.
Kern des aktuellen Verfahrens ist eine Garantieerklärung gegenüber einem Investor beziehungsweise den Vertretern einer Privatstiftung, hinter der nach Medienangaben der frühere Strabag‑Chef Hans-Peter Haselsteiner stehen dürfte. Nach Darstellung der WKStA soll Benko eine „wahrheitswidrige Garantie“ abgegeben und die Stiftung dadurch um rund fünf Millionen Euro geschädigt haben. Konkret sollen die vertretungsbefugten Organe der Stiftung durch die Erklärung dazu veranlasst worden sein, etwa 3,3 Millionen Euro an die Signa Holding zu überweisen und auf die Rückforderung weiterer rund 1,7 Millionen Euro zu verzichten.
Der Garantie zufolge sei der Privatstiftung eine Zahlung von in Summe rund fünf Millionen Euro bis spätestens 30. Juni 2024 zugesichert worden. Diese Rückzahlung sei jedoch ausgeblieben, so die Anklagebehörde. Dadurch soll die Stiftung in Millionenhöhe geschädigt und im Gegenzug die Signa Holding sowie eine weitere Gesellschaft unrechtmäßig bereichert worden sein. Neben dieser angeblichen Falschgarantie wirft die WKStA Benko vor, im Zuge der Signa-Insolvenz sowie seiner persönlichen Insolvenz ein Jagdgewehr im Wert von rund 80.000 Euro vor den Gläubigern verborgen zu haben und damit deren Befriedigung vereitelt zu haben.
Benko war über zwei Jahrzehnte eine der prominentesten Unternehmerfiguren im deutschsprachigen Raum. Mit einem dicht verschachtelten Geflecht aus Immobilien- und Handelsbeteiligungen baute er das Signa-Imperium auf, zu dem zeitweise auch die deutschen Warenhausketten Karstadt und Kaufhof gehörten. Steigende Zinsen, höhere Baukosten und aggressive Zukäufe trugen letztlich zur Insolvenz des Konzerns bei. Im weitläufigen Signa-Komplex wird der ehemalige Milliardär von der WKStA unter anderem wegen Betrugs, Untreue und Bankrotts verdächtigt; weitere Anklagen hält die Behörde für möglich.
Der Investor ist bereits in zwei ähnlichen Verfahren verurteilt worden, beide Urteile sind jedoch noch nicht rechtskräftig. Im Oktober 2025 verhängte ein Gericht eine zweijährige Haftstrafe, im Dezember desselben Jahres folgte wegen Schädigung von Gläubigern eine weitere Verurteilung zu 15 Monaten auf Bewährung sowie eine Geldstrafe. Parallel dazu laufen mehrere Ermittlungsstränge, die auch andere frühere Führungskräfte aus dem Signa-Umfeld betreffen. Die jetzige Anklage erhöht den juristischen Druck auf Benko weiter und dürfte die Aufarbeitung einer der spektakulärsten Unternehmenspleiten im deutschsprachigen Raum zusätzlich in die Länge ziehen.
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