TREMFYA® (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowe
The firsta approved fully-human, dual-acting interleukin-23 (IL-23) inhibitor in moderately to severely active ulcerative colitis,1,2,3,4,5 guselkumab showed statistically higher rates of endoscopic normalisationb at Week 44 compared with placebo.2,6,7,8,9
Guselkumab is now approved for the treatment of ulcerative colitis in addition to existing indications of plaque psoriasis and psoriatic arthritis in the European Union.2
Beerse, Belgium (25 April 2025) – Johnson & Johnson today announced that the European Commission (EC) has approved a Marketing Authorisation (MA) for TREMFYA® (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.2 UC is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed.10
Guselkumab is the firsta approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64c, a receptor on cells that produce IL-23.1,2,3,4,5,11 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases,d including UC.11
“Treatment with guselkumab led to significant improvement in the chronic symptoms of ulcerative colitis with the capability of normalising the appearance of the intestinal lining,” said Laurent Peyrin-Biroulet, M.D., Ph.D., Head of the Inflammatory Bowel Disease (IBD) Unit at Nancy University Hospital in France and study investigator. “This approval represents a significant advancement in managing this chronic inflammatory disease.”
The EC approval is supported by data from the QUASAR programme, which consists of the Phase 2b induction dose-ranging study and the Phase 3 induction and maintenance studies, evaluating the efficacy and safety of guselkumab in adult patients with moderately to severely active UC who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.2,6,7,8,9 Highlights from QUASAR showed:2,7
- In the QUASAR maintenance study, 45% of patients receiving guselkumab 100mg subcutaneous (SC) maintenance every eight weeks (q8w) and 50% of patients receiving guselkumab 200mg SC every four weeks (q4w) achieved the primary endpoint of clinical remissione at Week 44 compared to 19% placebo-treated patients (p<0.001).
- Also in the maintenance study, 35% of patients (100 mg q8w) and 34% (200 mg q4w) achieved endoscopic normalisationb at Week 44 with SC maintenance therapy compared to 15% placebo-treated patients (p<0.001).
The safety results were consistent with the known safety profile of guselkumab in approved indications for psoriasis (Pso) and psoriatic arthritis (PsA).2
“There is significant need for new ulcerative colitis therapies that offer meaningful improvements in symptoms and the promise of remission – both overall clinical remission and visible healing of the colon through endoscopic normalisation,”7,12 said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, J&J Innovative Medicine EMEA. “This approval builds on our sustained efforts to help improve the quality of life of patients, which can be significantly impacted from both a physical and mental health perspective. We look forward to seeing guselkumab continue to raise the bar of efficacy and become the new standard of care in the treatment of UC.”7
For the treatment of UC, guselkumab is administered as a 200 mg induction dose intravenously at weeks 0, 4, and 8.2 The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks (q8w) thereafter. Alternatively, for patients who do not show adequate therapeutic benefit to induction treatment according to clinical judgement, a maintenance dose of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w), may be considered.2
This EC approval marks the third indication approved for guselkumab in the European Union (EU),2 which builds on Johnson & Johnson’s nearly 30-year legacy of immunology innovation. Guselkumab first received approval in the EU in November 2017 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy1 and received subsequent approval in November 2020 for the treatment of 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.13
The EC is also currently reviewing the positive CHMP opinion to expand MA for guselkumab for the treatment of adult patients with moderately to severely active Crohn’s disease. The EC Decision is expected later this year.
Editor’s Notes:
a) Guselkumab was the first IL-23 inhibitor to be approved in November 2017 for first-line treatment of moderate-to-severe plaque psoriasis.1,2,3,4,5
b) Also known as endoscopic remission. It is defined as a Mayo Endoscopic Subscore (MES) of 0.2,14
c) CD64+ cells are the predominant source of IL-23 in IBD. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent.15,16
d) Based on in vitro studies in an inflammatory monocyte model.15
e) Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.2,7
ABOUT THE QUASAR PROGRAMME (EudraCT 2018-004002-25)6
QUASAR is a randomised, double-blind, placebo-controlled, parallel group, multicentre, seamless Phase 2b/3 programme designed to evaluate the efficacy and safety of guselkumab, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who experienced an inadequate response or who demonstrate intolerance to conventional therapy (e.g., thiopurines or corticosteroids), other biologics and/or JAK inhibitors (i.e., tumor necrosis factor [TNF]-alpha antagonists, vedolizumab, and/or JAK inhibitors (tofacitinib)).7 QUASAR includes a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomised withdrawal maintenance study, through a total of five years.7,14 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.6 Full results are available in The Lancet.7
ABOUT ULCERATIVE COLITIS
Ulcerative colitis is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus.10 It is the result of the immune system’s overactive response.10 Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhoea, abdominal pain, loss of appetite, weight loss, and fatigue.17 Ulcerative colitis patients also have increased rates of depression.18
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-23.1,2,3,4.5,11 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.15
Guselkumab is approved in the EU for the treatment of moderate to severe plaque psoriasis (Pso) in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy.2 It 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 Pso who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active PsA.
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 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-Cilag International NV, 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 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 or on request from Johnson & Johnson. None of Janssen-Cilag International NV, 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 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.
2 J&J Data on file (RF-433976). European Medicines Agency. Updated TREMFYA Summary of Product Characteristics. Accessed April 2025.
3 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.
4 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.
5 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 April 2025.
6 EU Clinical Trials Register: Clinicaltrialsregister.eu. A Phase 2b/3, randomised, double-blind, placebo-controlled, parallel-group, multicentre protocol to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (QUASAR). Identifier: 2018-004002-25. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004002-25/SE/. Accessed April 2025.
7 Rubin, D. et al. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 3 Double-Blind, Randomised, Placebo-Controlled Induction and Maintenance Studies. The Lancet. December 2024. Available at: https://doi.org/10.1016/S0140-6736(24)01927-5.
8 Allegretti, J, et al. The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: Results from the Phase 3 QUASAR induction study. Presented at Digestive Disease Week, May 6-9.
9 Peyrin-Biroulet L, et al. Guselkumab in patients with moderately to severely active ulcerative colitis: QUASAR Phase 2b induction study. Gastroenterology. 2023 Dec;165(6):1443-1457. doi: 10.1053/j.gastro.2023.08.038. Epub 2023 Sep 1. PMID: 37659673.
10 Crohn’s & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed April 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 April 2025.
12 Turner D, Ricciuto A, Lewis A, et al; International Organization for the Study of IBD. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology 2021; 160: 1570–83.
13 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.
14 National Institutes of Health: ClinicalTrials.gov. A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis. Protocol CNTO1959UCO3001; Phase 2b/3 Amendment 3. Available at:https://cdn.clinicaltrials.gov/large-docs/45/NCT04033445/Prot_000.pdf. 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. Accessed April 2025.
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 NHS. Overview Ulcerative colitis. Available at: https://www.nhs.uk/conditions/ulcerative-colitis/. Accessed April 2025.
18 Barberio, B. et al. Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and meta-analysis. The Lancet Gastroenterology & Hepatology. 2021 May;6(5):359-370. Available at: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00014-5/abstract.
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.
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