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

Rhea-AI Summary

AbbVie (NYSE:ABBV) announced U.S. FDA approval of SKYRIZI (risankizumab-rzaa) for children six years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis.

The approval adds a 55 mg pre-filled syringe for patients under 40 kg and keeps 150 mg options for those 40 kg or more, making SKYRIZI the first and only IL-23 inhibitor approved in the U.S. for pediatric patients six and older under 40 kg with plaque psoriasis or psoriatic arthritis. Pediatric safety data were consistent with the established adult plaque psoriasis profile, supported by Phase 3 OptIMMize trials and pharmacokinetic modeling. AbbVie also highlights co-pay and assistance programs to help eligible families access treatment.

Positive

• FDA approval for SKYRIZI in children ≥6 with plaque psoriasis or psoriatic arthritis
• First and only IL-23 inhibitor approved for U.S. pediatric patients under 40 kg with psoriatic disease
• New 55 mg pre-filled syringe enables weight-based dosing for patients weighing less than 40 kg
• Pediatric safety profile consistent with established adult plaque psoriasis SKYRIZI safety data
• Co-pay support may lower out-of-pocket costs to $0 per month for eligible commercially insured patients

Negative

• None.

News Market Reaction – ABBV

+0.38%

+0.38% Session close to close

In the Jun 29 session, ABBV gained 0.38%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds a pediatric indication and weight-based dosing for SKYRIZI, broadening reach ...

Analysis

This announcement adds a pediatric indication and weight-based dosing for SKYRIZI, broadening reach in psoriatic disease. Prior FDA approvals moved ABBV shares by about 0.4% on average. Investors may watch uptake in the sizable pediatric population.

Key Figures

Pediatric age range: ≥6 years New syringe dose: 55 mg Existing syringe/pen dose: 150 mg +5 more

8 metrics

Pediatric age range ≥6 years FDA approval population for plaque psoriasis and psoriatic arthritis

New syringe dose 55 mg Pre-filled syringe for patients weighing less than 40 kg

Existing syringe/pen dose 150 mg PFS and Pen for patients weighing 40 kg or greater

Lower weight threshold <40 kg Weight-based dosing cutoff for 55 mg SKYRIZI syringe

Higher weight threshold ≥40 kg Weight-based dosing cutoff for 150 mg PFS and Pen

Early-onset share 30% People with psoriasis who experience symptoms before age 18

Annual pediatric psoriasis cases 20,000 children Children under 10 diagnosed with psoriasis each year in the U.S.

Children with psoriatic arthritis 14,000 children Estimated U.S. pediatric population impacted by psoriatic arthritis

Previous Fda approval Reports

5 past events · Latest: Jun 16 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 16	Aesthetic filler approval	Positive	+0.4%	FDA approval for SKINVIVE by JUVÉDERM for neck appearance improvement.
May 27	Oncology drug approval	Positive	+1.5%	FDA approval of DECNUPAZ for ultra-rare BPDCN blood cancer patients.
Feb 20	CLL combo approval	Positive	+0.2%	FDA approval of VENCLEXTA plus acalabrutinib regimen for first-line CLL.
Nov 18	Lymphoma combo approval	Positive	-0.1%	FDA approval of EPKINLY combo for relapsed or refractory follicular lymphoma.
Oct 13	Label expansion	Positive	-0.1%	FDA label update expanding RINVOQ use in inflammatory bowel disease.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent FDA approvals for ABBV have typically produced modest, mixed share-price moves, with small gains slightly more common than declines.

Key Terms

il-23 inhibitor, phototherapy, population pharmacokinetic modeling, pasi

4 terms

il-23 inhibitor medical

"SKYRIZI becomes the first and only IL-23 inhibitor approved in the U.S. for pediatric patients"

An IL-23 inhibitor is a medicine that blocks the immune-signaling protein interleukin-23, which helps drive excessive inflammation in certain autoimmune and inflammatory conditions. By dampening that specific signal, these drugs can reduce symptoms and tissue damage without broadly suppressing the whole immune system. For investors, IL-23 inhibitors are important because they are often high-value biologic therapies with clear clinical targets and market potential, but their commercial success depends on trial results, safety, and pricing.

phototherapy medical

"moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy"

Phototherapy is a medical treatment that uses specific wavelengths of light to change biological processes in the body—like easing newborn jaundice, treating skin conditions, or improving mood in seasonal depression. Investors care because demand, regulatory approvals, device makers, and reimbursement rules determine how broadly the therapy is adopted; successful clinical results or new, easier-to-use devices can create business growth similar to a new tool that suddenly makes a common job faster and cheaper.

population pharmacokinetic modeling medical

"supported by the OptIMMize program as well as population pharmacokinetic modeling and simulation"

Population pharmacokinetic modeling is a statistical method that describes how a medicine is absorbed, distributed, broken down and removed from the body across many people, capturing typical behavior and differences among subgroups. Think of it as a traffic map showing how various types of drivers (age, weight, kidney function) affect travel time; for investors it informs dosing decisions, safety profiles, regulatory approval risk and potential market size by predicting how broadly and safely a therapy can be used.

pasi medical

"Week 16... risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses"

PASI is the Psoriasis Area and Severity Index, a single number that combines how much of the body is covered by psoriasis and how severe the lesions are (redness, thickness and scaling). Think of it like measuring both the size and intensity of a stain on clothing — the higher the score, the worse the condition; drug trials report percent reductions in PASI to show effectiveness. Investors watch PASI results because larger, consistent improvements drive regulatory approvals, market uptake and revenue potential for therapies.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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:

fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, or throat

trouble breathing or throat tightness chest tightness skin rash, hives itching

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:

fever, sweats, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches

warm, red, or painful skin or sores on your body different from your psoriasis weight loss

diarrhea or stomach pain burning when you urinate or urinating more often than normal

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. 

U.S. Media: Carleigh Kmetz carleigh.kmetz@abbvie.com Global Media: Mary Byun mary.byun@abbvie.com

Investors: Liz Shea liz.shea@abbvie.com

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.

View original content:https://www.prnewswire.com/news-releases/skyrizi-risankizumab-rzaa-now-fda-approved-for-pediatric-use-in-psoriatic-disease-302812335.html

SOURCE AbbVie

FAQ

What did AbbVie (ABBV) announce about SKYRIZI FDA approval for pediatric patients on June 26, 2026?

AbbVie announced FDA approval of SKYRIZI for children six and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis. According to AbbVie, this extends SKYRIZI’s use beyond adults to eligible pediatric patients who are candidates for systemic therapy or phototherapy.

For which pediatric conditions is SKYRIZI (ABBV) now FDA approved in the United States?

SKYRIZI is now approved for children six years and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis. According to AbbVie, this includes those suitable for systemic therapy or phototherapy, addressing both skin disease and joint involvement in pediatric psoriatic disease.

What are the new SKYRIZI dosing options for children under and over 40 kg (ABBV)?

Children under 40 kg can receive SKYRIZI using a new 55 mg pre-filled syringe, while those 40 kg or more use the existing 150 mg pre-filled syringe or Pen. According to AbbVie, these weight-based options help tailor dosing for a broad pediatric age and weight range.

Why is the 2026 SKYRIZI pediatric approval significant for IL-23 inhibitors and ABBV shareholders?

SKYRIZI is now the first and only IL-23 inhibitor approved in the U.S. for pediatric patients six and older under 40 kg with plaque psoriasis or psoriatic arthritis. According to AbbVie, this unique positioning may strengthen SKYRIZI’s role in the psoriatic disease treatment landscape.

What clinical data supported the SKYRIZI pediatric FDA approval for psoriasis and psoriatic arthritis (ABBV)?

The approval is supported by Phase 3 OptIMMize psoriasis trials, including pharmacokinetic cohorts, an assessor-blinded active-controlled cohort, and an open-label cohort. According to AbbVie, population pharmacokinetic modeling from adult psoriatic arthritis studies also informed pediatric dosing and supported regulatory review.

How did SKYRIZI perform in the OptIMMize pediatric psoriasis trial according to AbbVie?

At Week 16 in part 2 of OptIMMize, risankizumab showed clinically meaningful sPGA and PASI improvements, with responses maintained long term on continued treatment. According to AbbVie, these responses, alongside weight-based dosing, may help physicians manage diverse pediatric psoriatic disease presentations.

What patient assistance and co-pay support does AbbVie offer for pediatric SKYRIZI users (ABBV)?

AbbVie offers a patient support program and co-pay card that may reduce eligible, commercially insured patients’ SKYRIZI costs to as little as $0 per month. According to AbbVie, the myAbbVie Assist program can provide SKYRIZI at no charge to qualifying underinsured or uninsured patients.