TREMFYA (Guselkumab) Receives Positive CHMP Opinion For Subcutaneous Induction Regimen In Ulcerative Colitis, A First For An IL-23 Inhibitor

2025-09-19 10:16:29

(MENAFN- GlobeNewsWire - Nasdaq) Recommendation based on the findings from the Phase 3 ASTRO study in ulcerative colitis.¹^,²^,³

Guselkumab has the potential to become the first IL-23 inhibitor to offer both subcutaneous and intravenous induction options in ulcerative colitis, providing flexibility and simplicity for patients and physicians.^1,⁴

Beerse, Belgium (19 September 2025) – Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an expansion of Marketing Authorisation for 400mg subcutaneous (SC) induction at Weeks 0, 4, and 8 of TREMFYA^® (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.¹

This positive CHMP opinion builds on the recent European Commission (EC) approval of guselkumab for UC in April 2025,⁵ which included a 200 mg intravenous (IV) induction regimen at Weeks 0, 4, and 8 followed by either 100 mg or 200 mg SC maintenance dose regimens every 8 (q8w) or 4 (q4w) weeks,⁵ respectively. In addition, this positive opinion follows the approval of guselkumab in Crohn's disease (CD) in May 2025 which included both SC and IV options for induction and SC maintenance treatment.⁶ The 400 mg SC induction regimen in UC provides an additional option to IV administration and offers flexibility,¹ with several studies indicating a preference for SC over IV administration.⁷^,⁸^,⁹^,¹⁰^,¹¹

This notable positive opinion is based on data from the Phase 3 ASTRO study which evaluated the efficacy and safety of guselkumab 400 mg SC induction at Weeks 0, 4, and 8 followed by guselkumab 100 mg q8w or 200 mg q4w SC maintenance therapy in patients with moderately to severely active UC.^1,^2,3 Data through Week 24 showed patients treated with guselkumab 400 mg SC induction followed by SC maintenance dose regimens demonstrated statistically significant and clinically meaningful improvements across the primary endpoint and all secondary endpoints, including clinical and endoscopic (including histologic-endoscopic) measures, compared with patients receiving placebo.¹^,3 Safety results were consistent with the known safety profile of guselkumab in approved indications, and in line with results seen from the GRAVITI study which evaluated SC induction administration of guselkumab in CD.^1,⁴

“Today's positive opinion marks a meaningful step forward in the treatment of UC, with guselkumab potentially becoming the first IL-23 inhibitor to offer a fully subcutaneous induction and maintenance regimen”,⁴^,¹²^,¹³^,¹⁴^,¹⁵ said Mark Graham, Senior Director, Therapeutic Area Head, Immunology, J&J Innovative Medicine EMEA.“This novel approach offers additional choice and simplicity for patients, caregivers and healthcare professionals, empowering them to choose a treatment regimen tailored to individual needs and lifestyles.¹ It underscores our commitment to delivering innovative, patient-centric solutions that help improve quality of life for those living with inflammatory bowel disease.”

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-23.⁴^,^12,13,14,15 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 UC and CD.¹⁵^,¹⁶ Guselkumab is approved in the European Union (EU) for the treatment of adults with moderate-to-severe psoriasis, active psoriatic arthritis, moderately to severely active UC and moderately to severely active CD.⁴

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

ABOUT THE ASTRO STUDY (EudraCT 2023-504719-34) ²

ASTRO is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, treat-through Phase 3 study designed to evaluate the efficacy and safety of guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors.²^,3 Patients (n = 418) were randomised 1:1:1 to receive guselkumab 400 mg SC induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg SC every 4 weeks (q4w); or guselkumab 400 mg SC induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg SC every 8 weeks (q8w); or placebo.^1,² The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR programme which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.¹^,^3,¹⁷

ABOUT THE GRAVITI PHASE 3 STUDY (EudraCT 2020-006165-11) ¹⁸

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).^4,¹⁸The 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.⁴

ABOUT THE QUASAR PROGRAMME (EudraCT 2018-004002-25) ¹⁹

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)).²⁰ 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.^20,²¹ Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.¹⁹ Full results are available in The Lancet .²⁰

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.²² It is the result of the immune system's overactive response.²² 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.²³ Ulcerative colitis patients also have increased rates of depression.²⁴

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.^{4,12,13,14,15} Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known.¹⁶

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.⁴ It is also approved for 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 treatment⁴ and for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.⁴ It is also approved in the U.S,²⁵ Canada,²⁶ Japan²⁷ 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 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).⁴

Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab:

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 . 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 , 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 J&J Data on file (RF-474846). Janssen Research & Development Clinical Overview. Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis – SC Induction. Accessed September 2025.
² EU Clinical Trials Register. A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: EudraCT 2023-504719-34-00. Available at: . Accessed September 2025.
³ Janssen Research & Development. Clinical Protocol. A Phase 3, 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 Ulcerative Colitis. Accessed September 2025.
⁴ European Medicines Agency. Tremfya (guselkumab) Summary of Product Characteristics. Available at: . Accessed September 2025.
⁵ 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: . Accessed September 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: . Accessed September 2025.
⁷ Bittner, B, et al. Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs. 2018;32(5), 425–440. Available at: . Accessed September 2025.
⁸ De Cock, E, et al. Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries. PloS One. 2016;11(6), e0157957. Available at: . Accessed September 2025.
⁹ Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2), 105–116. Available at: . Accessed September 2025.
¹⁰ Tetteh, E. K., and Morris, S. Evaluating the administration costs of biologic drugs: development of a cost algorithm. Health economics review. 2014;4(1), 26. Available at: . Accessed September 2025.
¹¹ Usmani, S. Z, et al. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. Journal of cancer research and clinical oncology. 2021;147(2), 619–631. Available at: . Accessed September 2025.
¹² EU SmPC: European Medicines Agency. Ilumetri Summary of Product Characteristics. Available at: . Accessed September 2025.
¹³ EU SmPC: European Medicines Agency. Skyrizi Summary of Product Characteristics. Available at: . Accessed September 2025.
¹⁴ Electronic Medicines Compendium. EU SmPC: European Medicines Agency. Omvoh Summary of Product Characteristics. Available at: . Accessed September 2025.
¹⁵ 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: . Accessed September 2025.
¹⁶ 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 September 2025.
¹⁷ 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: . Accessed September 2025.
¹⁸ EU Clinical Trials Register. Clinicaltrialsregister. 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: . Accessed September 2025.
¹⁹ EU Clinical Trials Register: 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: . Accessed September 2025.
²⁰ 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: . Accessed September 2025.
²¹ National Institutes of Health: 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: . Accessed September 2025.
²² Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed September 2025.
²³ NHS. Overview Ulcerative colitis. Available at: . Accessed September 2025.
²⁴ Barberio, B. et al. Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and Lancet Gastroenterology & Hepatology. 2021 May;6(5):359-370. Available at: . Accessed September 2025.
²⁵ US Food and Drug Administration. TREMFYA^® Prescribing Information. Available at: . Accessed September 2025.
²⁶ The Canadian Agency for Drugs & Technologies in Health. TREMFYA^® prescribing information. Available at: . Accessed September 2025.
²⁷ Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at: . Accessed September 2025.

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