U.S. FDA approves TREMFYA® (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor
Johnson & Johnson (NYSE:JNJ) announced that the FDA has approved TREMFYA® (guselkumab) for treating children six years and older weighing at least 40 kg with moderate to severe plaque psoriasis and active psoriatic arthritis. This marks TREMFYA® as the first and only IL-23 inhibitor approved for these pediatric indications.
The approval was based on the Phase 3 PROTOSTAR study, which demonstrated significant efficacy: 56% of patients achieved PASI 90 compared to 16% on placebo, and 66% achieved high skin clearance (IGA score 0/1) versus 16% on placebo at Week 16. The treatment will be administered via subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.
This approval addresses a significant market, targeting approximately 20,000 children under 10 diagnosed with plaque psoriasis annually and 14,000 children affected by psoriatic arthritis.
Johnson & Johnson (NYSE:JNJ) ha annunciato che la FDA ha approvato TREMFYA® (guselkumab) per il trattamento di bambini di sei anni e oltre che pesano almeno 40 kg con psoriasi a placche moderata-severa e artrite psoriasica attiva. Questo segna TREMFYA® come il primo e unico inibitore IL-23 approvato per queste indicazioni pediatriche. L'approvazione si basa sullo studio di fase 3 PROTOSTAR, che ha dimostrato una significativa efficacia: il 56% dei pazienti ha raggiunto PASI 90 rispetto al 16% con placebo, e il 66% ha ottenuto un'alta clearing della pelle (punteggio IGA 0/1) contro 16% placebo alla settimana 16. Il trattamento sarà somministrato per via sottocutanea al giorno 0, al giorno 4 e ogni 8 settimane a partire dalla settimana 4. Questa approvazione riguarda un mercato significativo, stimando circa 20.000 bambini sotto i 10 anni diagnosticati con psoriasi a placche ogni anno e 14.000 bambini affetti da artrite psoriasica.
Johnson & Johnson (NYSE:JNJ) anunció que la FDA ha aprobado TREMFYA® (guselkumab) para tratar a niños de seis años en adelante que pesen al menos 40 kg con psoriasis en placa de moderada a severa y artritis psoriásica activa. Esto convierte a TREMFYA® en el primer y único inhibidor IL-23 aprobado para estas indicaciones pediátricas. La aprobación se basó en el estudio de fase 3 PROTOSTAR, que demostró una eficacia significativa: el 56% de los pacientes logró PASI 90 frente al 16% con placebo, y el 66% logró una alta eliminación de la piel (puntuación IGA 0/1) frente al 16% con placebo en la semana 16. El tratamiento se administrará por inyección subcutánea en la Semana 0, Semana 4 y cada 8 semanas a partir de entonces. Esta aprobación aborda un mercado significativo, estimando aproximadamente 20.000 niños menores de 10 años diagnosticados con psoriasis en placa cada año y 14.000 niños afectados por artritis psoriásica.
Johnson & Johnson (NYSE:JNJ)가 FDA로부터 TREMFYA®(guselkumab)을 40 kg 이상의 체중을 가진 여섯 살 이상 아동의 중등도에서 중증의 판상 건선 및 활동성 건선성 관절염 치료에 사용할 수 있도록 승인받았다고 발표했습니다. 이는 TREMFYA®가 이러한 소아 적응증에 대해 IL-23 억제제 중 최초이자 유일한 승인이라는 의미입니다. 승인 근거는 3상 PROTOSTAR 연구로, 환자의 56%가 PASI 90을 달성했고 위약 대비 차이가 크며, 피부 클리어링이 높은 비율은 66%로 위약의 16%에 비해 우수했습니다(Week 16). 투여 방법은 주사로 Week 0, Week 4, 그리고 이후 8주 간격으로 시행됩니다.
이번 승인은 연간 판상 건선으로 진단받은 10세 미만 아동 약 2만 명과 건선성 관절염으로 영향을 받는 14,000명의 아동 등 상당한 시장을 대상으로 한다고 설명합니다.
Johnson & Johnson (NYSE:JNJ) a annoncé que la FDA a approuvé TREMFYA® (guselkumab) pour le traitement des enfants âgés de six ans et plus pesant au moins 40 kg atteint de psoriasis en plaques modéré à sévère et d’arthrite psoriasique active. Cela fait de TREMFYA® le premier et unique inhibiteur IL-23 approuvé pour ces indications pédiatriques. L’approbation est basée sur l’étude de phase 3 PROTOSTAR, qui a démontré une efficacité significative : 56% des patients ont atteint le PASI 90 par rapport à 16% sous placebo, et 66% ont obtenu une claire peau élevée (échelle IGA 0/1) contre 16% sous placebo à la semaine 16. Le traitement sera administré par injection sous-ccutanée à la semaine 0, semaine 4, puis toutes les 8 semaines. Cette approbation ouvre un marché important, estimé à environ 20 000 enfants de moins de 10 ans diagnostiqués avec le psoriasis en plaque chaque année et 14 000 enfants touchés par l’arthrite psoriasique.
Johnson & Johnson (NYSE:JNJ) gab bekannt, dass die FDA TREMFYA® (Guselkumab) zur Behandlung von Kindern ab sechs Jahren mit einem Gewicht von mindestens 40 kg mit moderater bis schwerer Plaque-Psoriasis und aktiver Psoriasis-Arthritis genehmigt hat. Damit ist TREMFYA® der erste und einzige IL-23-Inhibitor, der für diese pädiatrischen Indikationen zugelassen ist. Die Zulassung basierte auf der Phase-3-Studie PROTOSTAR, die eine signifikante Wirksamkeit zeigte: 56% der Patienten erreichten PASI 90 im Vergleich zu 16% Placebo, und 66% erreichten eine hohe Hautklarheit (IGA-Stufe 0/1) gegenüber 16% Placebo in Woche 16. Die Behandlung erfolgt subkutan in Woche 0, Woche 4 und danach alle 8 Wochen. Diese Zulassung erschließt einen bedeutenden Markt, der etwa 20.000 Kinder unter 10 Jahren, die jährlich mit Plaque-P psoriasis diagnostiziert werden, und 14.000 Kinder, die von Psoriasis-Arthritis betroffen sind umfasst.
Johnson & Johnson (NYSE:JNJ) أعلنت أن إدارة الغذاء والدواء الأمريكية وافقت على TREMFYA® (guselkumab) لعلاج الأطفال من سن السادسة فما فوق الذين يزنون 40 كغ على الأقل ويعانون من الصُّدفية اللويحية المتوسطة إلى الشديدة والتهاب المفاصل الصدفي النشط. وهذا يجعل TREMFYA® أول وأوحد مثبط IL-23 معتمد لهذه المؤشرات لدى الأطفال. الاعتماد استند إلى دراسة المرحلة الثالثة PROTOSTAR، التي أظهرت فاعلية كبيرة: 66% حققوا إزالة جلدية عالية و56% حققوا PASI 90 مقارنة بـ16% من الدواء الوهمي، في الأسبوع 16. سيُعطى العلاج عن طريق حقن تحت الجلد في الأسبوع 0، الأسبوع 4، وكل 8 أسابيع بعد ذلك. تنظر هذه الموافقة إلى سوق كبير يقدَّر بنحو 20,000 طفل دون سن العاشرة يُشخَّصون بصدفية اللويحات سنويًا و14,000 طفل مصاب بالتهاب المفاصل الصدفي.
Johnson & Johnson (NYSE:JNJ) 宣布 FDA 已批准 TREMFYA®（guselkumab）用于治疗体重至少40 kg、6岁及以上的儿童，其患有中度至重度斑块型银屑病及活动性银屑病关节炎。这使 TREMFYA® 成为首个也是唯一一个被批准用于这类儿科适应症的 IL-23 抑制剂。此批准基于第3阶段 PROTOSTAR 研究，显示显著疗效：56% 的患者达到 PASI 90，对比安慰剂的 16%，并且在 Week 16 时有 66% 实现高程度皮肤清除（IGA 0/1）对比安慰剂的 16%。治疗将于 Week 0、Week 4 及此后每8周一次以皮下注射给药。此次批准涉及一个重要市场，预计每年约有 20,000 名6岁以下被诊断为斑块型银屑病的儿童和 14,000 名受银屑病关节炎影响的儿童。]
- First and only IL-23 inhibitor approved for pediatric plaque psoriasis and psoriatic arthritis
- Strong efficacy with 56% of patients achieving PASI 90 vs 16% on placebo
- 66% of patients achieved high skin clearance vs 16% on placebo
- 40% of pediatric patients achieved complete clearance vs 4% on placebo
- Addresses large market of 34,000 affected children
- Convenient dosing schedule of every 8 weeks after initial doses
- Limited to children weighing at least 40 kg
- Requires ongoing subcutaneous injections for treatment
Insights
FDA approval of TREMFYA for pediatric indications strengthens J&J's immunology portfolio and expands market opportunity.
The FDA approval for TREMFYA® (guselkumab) in pediatric plaque psoriasis (PsO) and active psoriatic arthritis (PsA) represents a significant clinical and commercial milestone for Johnson & Johnson. This approval establishes TREMFYA as the first and only IL-23 inhibitor approved for these pediatric indications, building upon its existing adult approvals from 2017 and 2020.
The approval addresses substantial unmet needs in pediatric immunology, targeting approximately 20,000 children annually diagnosed with plaque PsO under age 10 and 14,000 children affected by PsA. The PROTOSTAR study data supporting the approval demonstrated impressive efficacy, with 56% of patients achieving PASI 90 and 66% achieving IGA scores of 0/1 at Week 16 (versus 16% for placebo in both measures).
Commercially, this approval strengthens J&J's position in the competitive immunology market by expanding TREMFYA's label to include a new patient demographic. The pediatric approval complements J&J's recent regulatory successes with TREMFYA in 2025, including approvals for ulcerative colitis and Crohn's disease in adults. The eight-week maintenance dosing schedule for pediatric patients aligns with the established adult regimen, potentially simplifying clinical adoption.
This approval enhances TREMFYA's competitive differentiation as a first-in-class therapy for these pediatric conditions, creating a potential competitive advantage against other immunology agents that lack similar pediatric indications. For J&J's broader immunology franchise, this approval demonstrates continued innovation and pipeline progression beyond initial indications, a critical factor for commercial sustainability in the highly competitive immunology market.
The FDA approval of TREMFYA® for pediatric patients represents a significant therapeutic advancement in managing both moderate to severe plaque psoriasis and active psoriatic arthritis in children. With the minimum age of 6 years and weight requirement of at least 40 kg, this approval addresses a critical treatment gap in pediatric immune-mediated disease management.
The PROTOSTAR clinical data is particularly compelling, demonstrating that nearly 40% of pediatric patients achieved complete skin clearance (IGA 0) at Week 16, compared to only 4% on placebo. This level of efficacy could substantially improve quality of life during developmentally crucial years. The established 8-week maintenance dosing regimen offers practical advantages for treatment adherence in pediatric care settings.
From a mechanistic perspective, TREMFYA's selective targeting of IL-23 through its dual-acting mechanism (blocking IL-23 while binding to CD64) provides targeted immunomodulation. This approach potentially offers a more favorable long-term safety profile compared to broader immunosuppressive agents, though ongoing vigilance for safety signals in pediatric populations remains essential.
For clinicians managing pediatric inflammatory conditions, having a biologic option with demonstrated efficacy across both skin and joint manifestations is valuable, as approximately one-third of psoriasis cases begin in childhood. The approval expands the pediatric immunology armamentarium beyond TNF inhibitors, offering an alternative mechanism of action for children who don't respond adequately to existing therapies. This advancement aligns with the evolving understanding of the central role IL-23 plays in driving both cutaneous and musculoskeletal manifestations of psoriatic disease.
TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six years and older, weighing at least 40 kg
Approval was based on PROTOSTAR study, which showed pediatric patients receiving TREMFYA ® achieved high levels of skin clearance vs. placebo at Week 16
These approvals for TREMFYA® offer important new treatment options for the roughly 20,000 children under 10 diagnosed with plaque PsO annually and the approximately 14,000 children impacted by PsA.1,2,3 One-third of PsO cases begin in childhood and the inflamed, scaly plaques caused by the chronic disease may be itchy or painful and can be highly stressful for children, leading to a potential long-term impact on those affected.4 Active PsA accounts for approximately five percent of the juvenile idiopathic arthritis population and is characterized by chronic joint inflammation, swelling and PsO, potentially impacting a child's physical ability and overall wellbeing.5
"Despite advancements in the treatment of pediatric plaque psoriasis and active psoriatic arthritis, there continues to be a significant gap in available therapies for these debilitating immune-mediated diseases that impact a child's physical and emotional wellbeing during critical years," said Vimal Hasmukh Prajapati, M.D., Clinical Associate Professor, University of Calgary, Councilor for the International Psoriasis Council, as well as Co-Founder and Co-Director of the Skin Health & Wellness Centre, Dermatology Research Institute, and Dermphi Centre, and study investigator. "The approval of TREMFYA offers physicians, as well as parents and care partners, an established treatment option with proven safety and demonstrated efficacy that can significantly improve the signs and symptoms in children living with these diseases."
The plaque PsO approval was based on results from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and supportive data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. In the PROTOSTAR study, the co-primary endpoints of Psoriasis Area Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) score of 0/1 were achieved at Week 16. Approximately
Approval of the active PsA indication was supported by evidence from pharmacokinetic extrapolation analyses from TREMFYA® PsO and PsA studies, including VOYAGE 1 and 2, DISCOVER 1 and 2 and PROTOSTAR. Findings from these analyses corroborate the efficacy and safety data from adults with PsO and PsA and children with moderate to severe plaque PsO to children with active PsA.
"Every child deserves to feel comfortable in their own skin and to be active without the limitations of joint pain, stiffness and swelling," said Brandee Pappalardo, PhD, MPH, Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine. "The approval of the first and only pediatric indications for an IL-23 inhibitor marks an important step forward not only for children, but also for the parents and care partners who support them every day. We remain committed to advancing research that demonstrates the long-term safety and efficacy of TREMFYA and to exploring its full potential for adult and pediatric patients."
For the treatment of pediatric plaque PsO and PsA, TREMFYA® is administered as a subcutaneous injection at Week 0, Week 4 and then every 8 weeks thereafter. The recommended dosage for moderate to severe pediatric plaque PsO and active PsA in these patients is 100 mg administered by subcutaneous injection using a 1 mL prefilled syringe.
"The physical and emotional impact of psoriasis and psoriatic arthritis can have children sitting on the sidelines of life, not attending social events because they are embarrassed of their plaques or their joint pain is too intense," said Leah M. Howard, JD, President and CEO, National Psoriasis Foundation. "The National Psoriasis Foundation welcomes any new treatment option that provides hope for relief from the pain, discomfort and the emotional burden of these conditions."
TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active PsA, moderate to severe PsO, moderate to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). Findings are based on in vitro studies.7,8,9,10,11
This approval is another important milestone for patients and is emblematic of Johnson & Johnson's continuous commitment to innovating to improve the lives of people living with chronic immune-mediated diseases. In 2025, Johnson & Johnson received FDA approvals of TREMFYA® (with subcutaneous induction) for the treatment of adults with moderately to severely active UC and CD, respectively. Additionally, Johnson & Johnson recently submitted an application to the FDA to include new evidence in the TREMFYA® label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in adults living with active psoriatic arthritis.
Editor's Notes:
a. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.
b. Vimal Hasmukh Prajapati is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
c. For active PsA, TREMFYA® may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (e.g., methotrexate).
d. Leah Howard has not been compensated for any media work.
e. Data extrapolation is the process of estimating future trends or effects based on previous observations. With limited pediatric patients available for clinical trial inclusion, researchers can extrapolate data from adult patient trials to determine the potential efficacy and tolerability of a treatment for the pediatric population.
f. TREMFYA® is not currently approved to treat pediatric moderately to severely active ulcerative colitis or Crohn's disease.
ABOUT THE PHASE 3 PROTOSTAR STUDY (
NCT03451851
)
PROTOSTAR is a Phase 3, multicenter, randomized, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered TREMFYA® for the treatment of chronic plaque PsO in pediatric patients six years of age and older. Co-primary endpoints of the study were Investigator's Global Assessment (IGA) 0/1 and PASI 90. Safety data through Week 16 showed that
ABOUT THE PHASE 3 VOYAGE STUDIES (
NCT02207231
and
NCT02207244
)
VOYAGE 1 and 2 were Phase 3 randomized, double-blind, placebo- and active comparator-controlled studies designed to evaluate the efficacy and safety of TREMFYA® compared with placebo and adalimumab in adults with moderate to severe plaque PsO. The co-primary endpoints of the studies were the proportions of patients receiving TREMFYA® versus patients receiving placebo achieving Investigator's Global Assessment (IGA) 0/1 (clear/almost clear skin) and PASI 90 at Week 16.13,14
ABOUT THE PHASE 3 DISCOVER STUDIES (
NCT03162796
and
NCT03158285
)
DISCOVER-1 was a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of TREMFYA® administered by subcutaneous injection in participants with active PsA, including those previously treated with one to two tumor necrosis factor inhibitors (TNFi). The primary endpoint was response of ACR20 at Week 24.15 DISCOVER-2 was a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of TREMFYA® administered by subcutaneous injection in biologic-naïve patients with active PsA. The primary endpoint was response of ACR20 at Week 24.16
ABOUT PEDIATRIC PLAQUE PSORIASIS
Plaque PsO is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. Almost one-third of PsO cases begin in childhood, with roughly 20,000 children under 10 diagnosed with psoriasis each year.1 Having visible skin disease can be highly stressful for children and adolescents and can have a long-term impact on those affected.4
ABOUT PEDIATRIC PSORIATIC ARTHRITIS
Juvenile psoriatic arthritis (jPsA) is a form of juvenile idiopathic arthritis (JIA) characterized by chronic joint inflammation, swelling and PsO. Juvenile PsA is relatively rare, accounting for approximately
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.
TREMFYA® is a prescription medicine approved in the
- adult and children 6 years of age and older who also weigh at least 88
pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). - adult and children 6 years and older who also weigh at least 88
pounds (40 kg) with active psoriatic arthritis. - adults with moderately to severely active ulcerative colitis.
- adults with moderately to severely active Crohn's disease.17
TREMFYA® is approved in
The legal manufacturer for TREMFYA® is Janssen Biotech, Inc.
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TREMFYA®?
TREMFYA® is a prescription medicine that may cause serious side effects, including:
- Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
|
o fainting, dizziness, feeling lightheaded (low blood pressure) o swelling of your face, eyelids, lips, mouth, tongue or throat |
o trouble breathing or throat tightness o chest tightness o skin rash, hives o itching |
- Infections. TREMFYA® 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 TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® 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 TREMFYA®.
Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
|
o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your body different from your psoriasis
|
o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often than normal
|
- Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:
|
o unexplained rash o vomiting o tiredness (fatigue) o yellowing of the skin or the whites of your eyes |
o nausea o stomach pain (abdominal) o loss of appetite o dark urine
|
Do not use TREMFYA ® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.
Before using TREMFYA®, 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 TREMFYA®?"
- 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). You should avoid receiving live vaccines during treatment with TREMFYA®. Children should be brought up to date with all vaccines before starting TREMFYA®
- are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.
- Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy.
- are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.
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 TREMFYA®?
TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?"
The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, bronchitis, feeling very tired (fatigue), fever (pyrexia), and skin rash.
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.
Use TREMFYA® exactly as your healthcare provider tells you to use it.
Please read the full Prescribing Information , including Medication Guide , for TREMFYA® and discuss any questions that you have with your doctor.
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 .
Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.
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Janssen Biotech, Inc. is a Johnson & Johnson company.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
1 National Psoriasis Foundation. Children with psoriasis. Available at: https://www.psoriasis.org/children-with-psoriasis/. Accessed September 2025.
2 Juvenile Idiopathic Arthritis / Pediatric Orthopaedic Society of
3 Brunello, Francesco et al. New Insights on Juvenile Psoriatic Arthritis. Frontiers in Pediatrics. 2022. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9199423/. Accessed September 2025.
4 Bronckers IM, Paller AS, van Geel MJ, van de Kerkhof PC, Seyger MM. Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities. Pediatric Drugs. 2015 Oct;17(5):373-84. doi: 10.1007/s40272-015-0137-1.
5 Jie Man Low, Kimme L. Hyrich, Coziana Ciurtin, Flora McErlane, Lucy R. Wedderburn, Nophar Geifman, Stephanie J. W. Shoop-Worrall, CAPS Principal Investigators. The impact of psoriasis on wellbeing and clinical outcomes in juvenile psoriatic arthritis. Rheumatology. 2024; 63:1273–1280: https://doi.org/10.1093/rheumatology/kead370.
6 Vimal H. Prajapati, Marieke M.B. Seyger, Dagmar Wilsmann-Theis, Erzsebet Szakos, Andrzej Kaszuba, Meg Jett, Bart van Hartingsveldt, Gigi Jiang, Shu Li, Cynthia DeKlotz, Amy S. Paller. Guselkumab for the Treatment of Moderate to Severe Plaque Psoriasis in Pediatric Patients: Results of a Phase 3, Randomized, Placebo-Controlled Study. Poster presented at: AAD Annual Meeting; March 7-11, 2025;
7 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023;
8 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.
9 TREMFYA® [Prescribing Information].
10 Skyrizi® [Prescribing Information].
11 Omvoh™ [Prescribing Information].
12 ClinicalTrials.gov. A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR). Identifier: NCT03451851. Available at: https://clinicaltrials.gov/study/NCT03451851. Accessed August 2025.
13 Clinicaltrials.gov. A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (VOYAGE 1). Identifier NCT02207231. https://www.clinicaltrials.gov/ct2/show/NCT02207231. Accessed August 2025.
14 Clinicaltrials.gov. A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment (VOYAGE 2). Identifier NCT02207244.
15 ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-Tumor Necrosis Factor (TNF) Alpha Agent(s) (DISCOVER 1). Identifier: NCT03162796. Available at: https://clinicaltrials.gov/ct2/show/NCT03162796. Accessed August 2025.
16 ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis. Identifier: NCT03158285. Available at: https://clinicaltrials.gov/ct2/show/NCT03158285. Accessed August 2025.
17 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed August 2025.
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SOURCE Johnson & Johnson
FAQ
What is the FDA approval for TREMFYA in pediatric patients?
What were the efficacy results of TREMFYA in the PROTOSTAR study?
How is TREMFYA administered for pediatric patients?
How many children could benefit from JNJ's TREMFYA approval?
What makes TREMFYA unique in treating pediatric psoriasis and psoriatic arthritis?
