SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease

• SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis
• Approval includes a new 55 mg pre-filled syringe to support weight-based dosing for those patients weighing less than 40 kg
• SKYRIZI becomes the first and only IL-23 inhibitor approved in the U.S. for pediatric patients six years of age and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis

NORTH CHICAGO, Ill., June 26, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI^® (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. A new 55 mg pre-filled syringe (PFS) has also been approved to support weight-based dosing for patients weighing less than 40 kg, while the currently available 150 mg PFS and Pen are approved for patients weighing 40 kg or greater.

"Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints – these conditions can shape daily life and disrupt important childhood experiences," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We are proud that SKYRIZI is now the first and only IL-23 inhibitor approved in the U.S. for pediatric patients six years of age and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis. For families navigating these chronic conditions, expanding access to treatments with proven efficacy supports improved disease management and extends established standards of care to younger patients."

Approximately 30% of people who develop psoriasis experience symptoms before age eighteen.¹ Each year, approximately 20,000 children under ten years old are diagnosed with psoriasis in the U.S., and an estimated 14,000 children are impacted by psoriatic arthritis.^1,2,3 Psoriasis and psoriatic arthritis symptoms in children can interfere with mobility and daily activities, with additional burden on caregivers.^4,5

"For children impacted by immune-mediated diseases, childhood can become shaped by doctor appointments, uncertainty and the emotional weight of living with a chronic disease," said Leah M. Howard, J.D., president and chief executive officer, National Psoriasis Foundation. "Having an approved treatment for both skin and joint disease available for our younger patients gives families another much-needed option and offers a measure of hope as they navigate the challenges of these diseases."

Data Supporting SKYRIZI Pediatric Approvals

The pediatric psoriasis approval is supported by data from the Phase 3 OptIMMize psoriasis clinical trial program (NCT04435600; NCT04862286), 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). The pediatric psoriatic arthritis approval is supported by the OptIMMize psoriasis clinical trial program as well as population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies.

The safety profile observed in pediatric plaque psoriasis patients treated with SKYRIZI was consistent with the established safety profile of SKYRIZI in adult patients with plaque psoriasis.

"At Week 16 in part 2 of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment," said Amy S. Paller, M.D., chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and study investigator in the OptIMMize program. "These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with plaque psoriasis or psoriatic arthritis."

Patient Access and Support

AbbVie is committed to helping people access SKYRIZI and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $0 per month for eligible, commercially insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides SKYRIZI at no charge to those who qualify. More information about this assistance program can be found at www.AbbVie.com/myAbbVieAssist.

About SKYRIZI^® (risankizumab-rzaa)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively 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.

SKYRIZI^® (risankizumab-rzaa) U.S. Uses and Important Safety Information

SKYRIZI is a prescription medicine used to treat:

• moderate to severe plaque psoriasis in adults and children 6 years of age and older who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
• active psoriatic arthritis in adults and children 6 years of age and older.
• moderate to severe Crohn's disease in adults.
• moderate to severe ulcerative colitis in adults.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?

SKYRIZI is a prescription medicine that may cause serious side effects, including:

Serious allergic reactions:

• Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:

Infections:

SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

• Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
• are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.
• become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?

SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

Liver problems may happen while being treated for Crohn's disease or ulcerative colitis: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and at least up to 12 weeks of treatment, and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.

The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash.

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 55 mg/0.37 mL prefilled syringe, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.

This is the most important information to know about SKYRIZI. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. 

Please click here for the Full Prescribing Information and Medication Guide.

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. Menter A et al. (2020). Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. Journal of the American Academy of Dermatology, 82(1), 161–201. https://doi.org/10.1016/j.jaad.2019.08.049
2. Brunello, Francesco et al. (2022). New Insights on Juvenile Psoriatic Arthritis. Frontiers in Pediatrics, 10, 884727. https://doi.org/10.3389/fped.2022.884727
3. Morgan, E. M., et al. (2019). Establishing an Updated Core Domain Set for Studies in Juvenile Idiopathic Arthritis: A Report from the OMERACT 2018 JIA Workshop. The Journal of Rheumatology, 46(8), 1006–1013. https://doi.org/10.3899/jrheum.181088  
4. Salman, A., et al. (2018). Impact of psoriasis in the quality of life of children, adolescents and their families: a cross-sectional study. Anais Brasileiros de Dermatologia, 93(6), 819–823. https://doi.org/10.1590/abd1806-4841.20186981
5. National Psoriasis Foundation. For Parents: Emotional Impact. Available at: https://www.psoriasis.org/our-spot-emotional-impact/. Accessed June 2026.

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SOURCE AbbVie