Beerse, Belgium (25 July 2025) – Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the Marketing Authorisation for a new 100 mg/1 mL single-dose pre-filled pen (PushPen) presentation of TREMFYA® (guselkumaba),1 for subcutaneous (SC) injection across all approved adult indications.1,2
This approval provides a flexible administration option for adult patients,b caregivers and healthcare professionals,2 by enabling a seamless transition from the initial 400 mg SC induction dose of guselkumab to the 100 mg SC maintenance dosec without interruption to Crohn’s disease (CD) treatment.1,2 In addition, the device simplifies the injection process for all adult indications with two patient-friendly steps: removing the cap and pressing it against the skin for automatic injection.1,2 Upon completion, a built-in mechanism conceals the needle, helping to reduce administration anxiety and needle accidents.2,3
The positive opinion is based on data from a Phase 1 study CNTO1959PSO10084 demonstrating that the pharmacokinetics, safety and immunogenicity of guselkumab administered via the 100 mg/1 mL pre-filled pen (PushPen) are comparable to those of the currently approved 100 mg/1 mL pre-filled syringe.2,4 A human factors validation study confirmed that the safety results were consistent with the known safety profile of guselkumab in approved indications in psoriasis, psoriatic arthritis, ulcerative colitis (UC) and CD.1,2,4 This builds on the successful platform used in the 200 mg/2 mL guselkumab pre-filled pen (PushPen) presentation, which received a European Commission (EC) decision on 23 April 2025.5
This new guselkumab 100 mg/1 mL solution for injection in a pre-filled pen (PushPen) does not require an immediate EC decision, and the CHMP opinion date is the formal approval date.
Editor’s Notes
a. Guselkumab is the first selective interleukin (IL)-23 p19-subunit inhibitor approved for both moderate-to-severe plaque psoriasis and active psoriatic arthritis, and more recently has received EC approval for expanded use in the treatment of moderately to severely active UC and CD.1,6,7,8,9,10
b. Previously approved administration solutions for guselkumab 100 mg/1 mL include a pre-filled syringe assembled with the UltraSafe Plus™ needle safety guard and the OnePress solution pre-filled pen.1
c. Both the 100 mg/1 mL and 200 mg/2 mL maintenance doses for guselkumab continue to be available.1
ABOUT THE CNTO1959PSO1008 PROGRAMME4
CNTO1959PSO1008 is a Phase 1, open-label, randomised, parallel group study which evaluated the relative bioavailability of 100 mg/1 mL guselkumab administered subcutaneously by two different devices in 250 healthy participants; the pre-filled PushPen (test device) and the 100 mg/1 mL pre-filled syringe assembled with the UltraSafe Plus™ needle safety guard (the reference device).4 Participants were randomised across the 2 arms in a 1:1 ratio, with 125 participants in the 100 mg/1.0 mL UltraSafe Plus™ needle safety guard group and 125 participants in the 1.0 mL pre-filled PushPen through a total of 16 weeks, including a 28 day screening phase.4
ABOUT GUSELKUMAB
Developed by Johnson & Johnson, guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.1,8,9,10,11 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.12
Guselkumab is also approved in the U.S,13 Canada,14 Japan15 and a number of other countries for the treatment of adults with moderate-to-severe psoriasis who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis.
Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab.
GUSELKUMAB IMPORTANT SAFETY INFORMATION
In controlled periods of clinical studies with guselkumab, adverse drug reactions (ADRs) that consisted of respiratory tract infections were very common (≥10 percent); increased transaminases, headaches, diarrhoea, arthralgia, and injection site reactions were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, urticaria and rash were uncommon ADRs (≥0.1 percent to <1 percent).16
Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf
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
www.innovativemedicine.jnj.com/emea. Follow us at
J&J Innovative Medicine Europe, Middle East & Africa (EMEA). Janssen-Cilag International NV, Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding 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 materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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 or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Media contact:
Sophie Daneau
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Investor contact:
Lauren Johnson
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CP-531897
July 2025
1 J&J Data on file (RF-471198). European Medicines Agency. Updated TREMFYA Summary of Product Characteristics. Accessed July 2025.
2 J&J Data on file (RF-471653). Janssen Research & Development Clinical Overview. TREMFYA 1Ml Prefilled Syringe Assembled with YpsoMate Autoinjector (PFS-Y) for Subcutaneous Administration. Accessed July 2025.
3 Coyne, M, et al. Impact of Routines and Rituals on Burden of Treatment, Patient Training, Cognitive Load, and Anxiety in Self-Injected Biologic Therapy. Patient Preference and Adherence. 2022,16, 2593–2607. Available at:
https://doi.org/10.2147/PPA.S375037. Accessed July 2025.
4 J&J Data on file (RF-471654). Clinical Study Report CNTO1959PSO1008. CNTO1959 TREMFYA (guselkumab). Accessed July 2025.
5 European Commission. Commission Implementing Decision of 23.4.2025 amending the marketing authorisation granted by Decision C(2017)7649 final for “Tremfya-Guselkumab”, a medicinal product for human use. Available at:
https://ec.europa.eu/health/documents/community-register/2025/20250423165812/dec_165812_en.pdf. Accessed July 2025.
6 Johnson & Johnson Innovative Medicine. European Commission approves TREMFYA® (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease. Available at:
https://innovativemedicine.jnj.com/emea/newsroom/european-commission-approves-tremfya-guselkumab-the-first-dual-acting-il-23-inhibitor-offering-both-subcutaneous-and-intravenous-induction-options-for-adult-patients-with-moderately-to-severely-active-crohns-disease. Accessed July 2025.
7 Johnson & Johnson Innovative Medicine. TREMFYA® (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease. Available at:
https://innovativemedicine.jnj.com/emea/newsroom/tremfya-guselkumab-receives-european-commission-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease. Accessed July 2025.
8 EU SmPC: European Medicines Agency. Ilumetri Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/en/documents/product-information/ilumetri-epar-product-information_en.pdf. Accessed July 2025.
9 EU SmPC: European Medicines Agency. Skyrizi Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed July 2025.
10 Electronic Medicines Compendium. EU SmPC: European Medicines Agency. Omvoh Summary of Product Characteristics. Available at:
https://www.medicines.org.uk/emc/product/14882/smpc#gref. Accessed July 2025.
11 Schinocca, C. et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: An overview. Frontiers in Immunology. 2021 Feb 22;12:321. Available at:
https://doi.org/10.3389/fimmu.2021.637829. Accessed July 2025.
12 Atreya, R, et al. Guselkumab binding to CD64+ IL-23–producing myeloid cells enhances potency for neutralizing IL-23 signaling. J Crohns Colitis. 2024;18(suppl):S470.
13 US Food and Drug Administration. TREMFYA® Prescribing Information. Available at:
https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed July 2025.
14 The Canadian Agency for Drugs & Technologies in Health. TREMFYA prescribing information. Available at:
https://pdf.hres.ca/dpd_pm/00042101.PDF. Accessed July 2025.
15 Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at:
https://www.pmda.go.jp/files/000234741.pdf. Accessed July 2025.
16 European Medicines Agency. Tremfya (guselkumab) Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf. Accessed July 2025.