TREMFYA® (guselkumab) induction therapy administered either intravenously (GALAXI 2 and 3) or subcutaneously (GRAVITI) achieved the co-primary endpoints of clinical remissiona and endoscopic responseb at Week 12 compared to placebo.1,2,3
Guselkumab demonstrated statistically significant and clinically meaningful improvements in clinical remissiona and endoscopic responseb at Week 48 compared to placebo in all three studies. 1,2,3
Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ustekinumab in endoscopic responseb and endoscopic remissionc both at Week 48, including the biologic naïve and prior biologic failure subgroups.1,2
Guselkumab European Commission approval in Crohn’s disease builds upon recent ulcerative colitis approval,4 marking the fourth indication for this dual-acting IL-23 inhibitor in the European Union.2
Beerse, Belgium (7 May 2025) – Johnson & Johnson today announced that the European Commission (EC) has approved a Marketing Authorisation (MA) for TREMFYA® (guselkumab), the first dual-actingd IL-23 inhibitor offering both intravenous (IV) and subcutaneous (SC) induction options,2,5,6,7 for the treatment of adults with moderately to severely active Crohn’s disease (CD)e who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. This milestone builds upon the recent EC approval of guselkumab in moderately to severely active ulcerative colitis (UC).4 CD and UC are the two main forms of inflammatory bowel disease (IBD), which affects over four million people in Europe.8 Guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64,f a receptor on cells that produce IL-23.2,5,6,7,9 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases,g including CD.9
“Despite the progress made in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,”10 said Professor Silvio Danese, Director, Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy. “The approval of guselkumab offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens and higher rates of endoscopic remission when compared to ustekinumab.2 Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and healthcare professionals that has not been available before.”2,6,7
This approval is supported by results from the Phase 3 GALAXI and GRAVITI programmes in moderately to severely active CD, in adults who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.1,2,3 Data from the pooled Phase 3 GALAXI 2 and 3 studies, which evaluated guselkumab IV induction and SC maintenance therapy, showed that guselkumab demonstrated greater efficacy compared to ustekinumab in endoscopic responseb and endoscopic remissionc at Week 48, the only IL-23 inhibitor to achieve this in a double-blinded registrational programme.2,11 The GRAVITI study evaluated guselkumab SC induction and maintenance therapy versus placebo following 12 weeks of induction and at 48 weeks of maintenance therapy.2,3 The results from these Phase 3 studies demonstrated the efficacy of IV or SC guselkumab in achieving clinical and endoscopic endpoints.2 Highlights from these registrational studies showed:
GALAXI
- In the pooled GALAXI 2 and 3 studies, at Week 48, guselkumab demonstrated greater efficacy in endoscopic responseb with 200 mg IV induction followed by 100 mg SC q8wh (48%) or 200 mg SC q4w (53%) compared to ustekinumab (37%).2
- Also in the pooled GALAXI 2 and 3 studies, endoscopic remissionc at Week 48 was achieved with greater efficacy with guselkumab 200 mg IV induction followed by 100 mg SC q8wh (25%) or 200 mg SC q4w (21%) compared to ustekinumab (16%).2
GRAVITI
- At Week 12, patients treated with guselkumab 400 mg SC induction achieved clinical remissiona (56%) and endoscopic responseb (41%) vs placebo (both 21%).2,12
- Clinical remissiona at Week 48 was achieved in patients treated with guselkumab 400 mg SC induction followed by 100mg SC q8wh (60%) or 200mg SC q4wi (66.1%) as maintenance vs placebo (17.1%).2,12
- Endoscopic reponseb at Week 48 was achieved in patients treated with guselkumab 400 mg SC induction followed by 100 mg SC q8w (44.3%) or 200mg SC q4w (51.3%) as maintenance vs placebo (6.8%).2,12
Safety results from both GALAXI studies and the GRAVITI study were consistent with the known safety profile of guselkumab in approved indications in psoriasis, psoriatic arthritis, and UC.2
“Guselkumab is the first approved fully-human, dual-acting IL-23 inhibitor that offers a fully subcutaneous option for moderately to severely active Crohn’s disease.2,5,6,7 With the approval of guselkumab, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes,”2 said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, J&J Innovative Medicine EMEA. “Guselkumab provides people living with Crohn’s disease and healthcare professionals a new treatment option that is supported by data from multiple Phase 3 studies, showing greater efficacy versus ustekinumab across endoscopic response and endoscopic remission.”1,2,3
For the treatment of CD, the recommended induction dose is 200 mg administered by IV infusion at Week 0, Week 4, and Week 8, or 400 mg administered by SC injection (given as two consecutive injections of 200 mg each) at Week 0, Week 4 and Week 8.2 After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w).2 Alternatively, for patients who do not show adequate therapeutic benefit to induction treatment according to clinical judgement, a maintenance dose regimen of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w) thereafter, may be considered.2
This EC approval marks the fourth approved indication for guselkumab in the European Union (EU).2 Guselkumab first received approval in the EU in November 2017 for the treatment of moderate-to-severe psoriasis in adults who are candidates for systemic therapy.13 In November 2020, guselkumab received EU approval for active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy,14 followed by moderately to active UC, who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment, in April 2025.4 These approvals underscore Johnson & Johnson’s long-standing legacy in innovation and commitment to patients living with chronic immune-mediated diseases, including IBD. In March 2025, Johnson & Johnson submitted an application to the European Medicines Agency (EMA), seeking approval for the subcutaneous (SC) induction regimen of guselkumab for the treatment of adults with moderately to severely active UC, based on results of the Phase 3 ASTRO study.
EDITOR’S NOTES
a) Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score of <150.2
b) Endoscopic response is defined as >50% improvement from baseline in Simple Endoscopic Score for CD (SES-CD) score or SES-CD score ≤2.2
c) Endoscopic remission is defined as SES-CD Score ≤ 2.2
d) “First dual-acting” based on approved selective IL-23 inhibitors for moderately to severely active CD as of May 2025.2,5,6,7
e) Moderately to severely active CD was defined as a CDAI score of ≥ 220 and ≤ 450 and a SES-CD of ≥ 6 (or ≥ 4 for patients with isolated ileal disease).2
f) CD64+ cells are the predominant source of IL-23 in CD. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent.15,16
g) Based on in vitro studies in an inflammatory monocyte model.15
h) q8w is defined as every eight weeks.2
i) q4w is defined as every four weeks.2
ABOUT THE GALAXI PROGRAMME (EudraCT 2017-002195-13)1
GALAXI is a double-blind, placebo-controlled, active-controlled (ustekinumab), parallel group, global, multicentre Phase 2/3 programme designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (immunomodulators, corticosteroids) and/or biologics (infliximab, adalimumab, certolizumab pegol, vedolizumab).1 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3, n=1021).1,2 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomised and includes a long-term extension that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years.1,2
ABOUT THE GRAVITI Phase 3 study (EudraCT 2020-006165-11)3
GRAVITI is a double-blind, placebo-controlled, parallel group, global, multicentre study to evaluate the efficacy and safety of guselkumab subcutaneous induction therapy in 347 participants with moderately to severely active Crohn’s disease with inadequate response or failure to tolerate previous conventional therapy (corticosteroids or immunomodulators) or biologic therapy (infliximab, adalimumab, certolizumab pegol, vedolizumab).2,3 The study has a treat-through design in which participants remained on the treatment to which they were initially randomised and includes a long-term extension that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years.2
ABOUT CROHN’S DISEASE
Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated nearly two million people across Europe.8 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.17 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.18 There is currently no cure for Crohn’s disease.10
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-23.2,5,6,7,9 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.15
Guselkumab is also approved in the U.S,19 Canada,20 Japan21 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 psoriasis 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, headache, 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).2
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 USTEKINUMAB
Ustekinumab is a fully human monoclonal antibody and is the first biologic treatment to selectively inhibit the IL-12 and IL-23 pathways.22, 23 In the EU, ustekinumab is approved for the treatment of adult and paediatric patients weighting at least 40 kg with moderate to severe Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist.22 Ustekinumab is also approved for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, or lost response to, or were intolerant to either conventional therapy or a biologic.22 In addition to CD and UC, ustekinumab has been approved for the treatment of two further immune-mediated conditions in the EU: plaque psoriasis and psoriatic arthritis.22
USTEKINUMAB IMPORTANT SAFETY INFORMATION
The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis and headache. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for STELARA is serious hypersensitivity reactions including anaphylaxis (see section 4.4). The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.22
Please refer to the Summary of Product Characteristics for full prescribing information for ustekinumab: https://www.ema.europa.eu/en/documents/product-information/stelara-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.
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1 EU Clinical Trials Register. Clinicaltrialsregister.eu. A Phase 2/3, randomised, double-blind, placebo- and active-controlled, parallel-group, multicentre protocol to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease (GALAXI). Identifier: 2017-002195-13. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-002195-13/ES. Accessed April 2025.
2 J&J Data on file (RF-433976). European Medicines Agency. Updated TREMFYA Summary of Product Characteristics. Accessed April 2025.
3 EU Clinical Trials Register. Clinicaltrialsregister.eu. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease (GRAVITI). Identifier: 2020-006165-11. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006165-11/ES. Accessed April 2025.
4 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 April 2025.
5 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 April 2025.
6 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 April 2025.
7 EU SmPC: European Medicines Agency. Omvoh Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/omvoh-epar-product-information_en.pdf. Accessed April 2025.
8 Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.
9 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 April 2025.
10 NHS. Crohn’s Disease Treatment. Available at: https://www.nhs.uk/conditions/crohns-disease/treatment/. Accessed April 2025
11 L Peyrin-Biroulet, et al. DOP10 Risankizumab Versus Ustekinumab for the Achievement of Endoscopic Outcomes in Patients With Moderate-to-Severe Crohn’s Disease: Results From the Phase 3b SEQUENCE Trial, Journal of Crohn's and Colitis, 2024;18;1:i90–i91, https://doi.org/10.1093/ecco-jcc/jjad212.0050
12 Hart A, et al. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants with Moderately to Severely Active Crohn’s Disease: Results form the Phase 3 GRAVITI Study. Gastroenterology. 2025;1-17. doi: 10.1053/j.gastro.2025.02.033
13 European Medicines Agency. Tremfya (guselkumab): An overview of Tremfya and why it is authorized in the EU. Available at: https://www.ema.europa.eu/en/documents/overview/tremfya-epar-medicine-overview_en.pdf. Accessed April 2025.
14 Johnson & Johnson Innovative Medicine. European Commission Approves Janssen’s TREMFYA®▼ (guselkumab), a First-in-Class Treatment for Active Psoriatic Arthritis (PsA). Available at: https://innovativemedicine.jnj.com/emea/european-commission-approves-janssens-tremfyarv-guselkumab-first-class-treatment-active-psoriatic. Accessed April 2025.
15 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
16 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
17 Crohn’s & Colitis Foundation. Causes of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed April 2025.
18 Crohn’s & Colitis Foundation. Signs and symptoms of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms. Accessed April 2025.
19 US Food and Drug Administration: Tremfya Product information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf. Accessed April 2025.
20 The Canadian Agency for Drugs & Technologies in Health. TREMFYA prescribing information. Available at: https://pdf.hres.ca/dpd_pm/00042101.PDF. Accessed April 2025.
21 Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed April 2025.
22 J&J Data on file (RF-451972). European Medicines Agency. Updated STELARA Summary of Product Characteristics. Accessed April 2025.
23 Benson, JM, et al. Discovery and mechanism of ustekinumab: a human monoclonal antibody targeting interleukin-12 and
interleukin-23 for treatment of immune-mediated disorders. MAbs. 2011 3(6):535-545.
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