TREMFYA® (guselkumab) receives positive CHMP opinion for treatment of adult patients with moderately to severely active ulcerative colitis

Recommendation based on the findings from the Phase 3 QUASAR programme in ulcerative colitis¹

Beerse, Belgium (28 February 2025) – Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the Marketing Authorisation for TREMFYA^® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.²

The positive CHMP opinion for guselkumab is based on data from the Phase 3 QUASAR programme.^1,3 In the QUASAR induction and maintenance studies, guselkumab achieved the primary endpoint of clinical remission in both studies and showed statistically significant and clinically meaningful improvements relative to placebo in symptoms.^1,3 Seven of nine prespecified, multiplicity-controlled major secondary endpoints, including clinical, endoscopic, histologic, symptomatic, and patient-reported outcome measures, were met in the induction study and all nine were met in the maintenance study for both dose regimens.^1,3,4,5 The safety results were consistent with the known safety profile of guselkumab in approved indications.^4,5

“We are very pleased that the CHMP has recommended guselkumab for the treatment of people living with moderately to severely active ulcerative colitis”, said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, J&J Innovative Medicine EMEA. “Ulcerative colitis affects over 2.5 million people in Europe,⁶ and is a chronic and debilitating condition which can have a significant impact on multiple aspects of a person’s life.⁷ Today’s decision is a step towards being able to offer an additional treatment option for patients, ultimately enhancing their health outcomes and quality of life.”¹

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.^2,8,9,10,11 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including ulcerative colitis and Crohn’s disease.¹² Guselkumab is approved in the European Union (EU) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy and 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.⁸

The European Commission will review the CHMP recommendation to determine issuing an expanded Marketing Authorisation, and a decision is expected in due course.

ABOUT THE QUASAR PROGRAMME (EudraCT 2018-004002-25)

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)).³ 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.^1,13 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.³ Full results are available in The Lancet.¹

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.¹⁴ It is the result of the immune system’s overactive response.¹⁴ 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.¹⁵ Ulcerative colitis patients also have increased rates of depression.¹⁶

ABOUT GUSELKUMAB

Developed by Johnson & Johnson, guselkumab (GUS) 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.^2,8,9,10,11 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.¹⁷

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.⁸ It is also approved in the U.S,¹⁸ Canada,¹⁹ Japan²⁰ 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).⁸

Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab in Pso and PsA: 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 or 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 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
² J&J Data on file (RF-452642). European Medicines Agency. Updated TREMFYA Summary of Product Characteristics. Accessed February 2025.
³ 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 February 2025.
⁴ 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.
⁵ 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.
⁶ Ng et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21^st century: a systematic review of population-based studies. The Lancet. October 2017. Available at: http://dx.doi.org/10.1016/ S0140-6736(17)32448-0
⁷ Guts UK. Ulcerative Colitis. Available at: https://www.gutscharity.org.uk/advice-and-information/conditions/ulcerative-colitis/. Accessed February 2025.
⁸ EU SmPC: European Medicines Agency. TREMFYA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf. Accessed February 2025.
⁹ 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 February 2025.
¹⁰ 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 February 2025.
¹¹ 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
¹² 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 February 2025.
¹³ 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 February 2025.
¹⁴ Crohn’s & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed February 2025^.
15 NHS. Overview Ulcerative colitis. Available at: https://www.nhs.uk/conditions/ulcerative-colitis/. Accessed February 2025.
¹⁶ 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
¹⁷ 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
¹⁸ US Food and Drug Administration: Tremfya Product information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf. Accessed February 2025.
¹⁹ The Canadian Agency for Drugs & Technologies in Health. TREMFYA prescribing information. Available at: https://pdf.hres.ca/dpd_pm/00042101.pdf. Accessed February 2025.
²⁰ Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed February 2025.

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