Beerse, Belgium (28 March 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 Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.3 This application included both subcutaneous (SC) and intravenous (IV) options for induction treatment. This follows a positive CHMP opinion for guselkumab for the treatment of patients with moderately to severely active ulcerative colitis earlier this year.4
The positive CHMP opinion for guselkumab for Crohn’s disease was based on a review of data from the Phase 3 GALAXI and GRAVITI programmes.1,2,3 In the GALAXI programme, at Week 12 guselkumab achieved the co-primary endpoints of clinical remissiona and endoscopic response,b and the major secondary endpoints of PRO-2 remissionc and fatigue response,d demonstrating statistically significant and clinically meaningful improvements in symptoms relative to placebo.3 These studies also showed a significantly greater proportion of patients were in corticosteroid-free clinical remission at Week 48 and endoscopic response at Week 48 in the guselkumab treated group compared to placebo.3
Significantly, from the pooled GALAXI 2 and 3 study results, guselkumab also demonstrated greater efficacy compared to ustekinumab in endoscopic response and endoscopic remissione at Week 48.3
In the Phase 3 GRAVITI study, a SC induction dose regimen was evaluated as an alternative to the IV induction dose regimen that was evaluated in the GALAXI 2 and 3 studies.2 In the GRAVITI study, both co-primary endpoints of clinical remission and endoscopic response at Week 12 relative to placebo were achieved.2,3 In addition, all secondary endpoints (PRO-2 remission and clinical response) at Week 12, and clinical remission at Week 24 demonstrated significant results compared with placebo.3
Safety results from both GALAXI studies and the GRAVITI study were consistent with the known safety profile of guselkumab in approved indications.3
“The results from the Phase 3 studies demonstrate guselkumab has the potential to become the only IL-23 inhibitor to offer both SC and IV induction options for Crohn’s disease”, said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, J&J Innovative Medicine EMEA. “Today’s positive opinion by the CHMP marks an important step forward in offering a potentially new and differentiated treatment option for people living with this chronic and debilitating condition, which affects around two million people in Europe.6 We look forward to the European Commission’s decision for both ulcerative colitis and Crohn’s disease and the opportunity to bring guselkumab to patients living with inflammatory bowel disease.”
Guselkumab is the first approved in-vitro fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.5,7,8,9 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including ulcerative colitis and Crohn’s disease.5,10 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.5
The European Commission will review the CHMP recommendation to determine issuing an expanded Marketing Authorisation, and a decision for use in Crohn’s disease is expected in due course.
EDITOR’S NOTES
a. Clinical remission is defined as CDAI score < 150.3
b. Endoscopic response is defined as ≥ 50% improvement from baseline in SES-CD score or SES-CD Score ≤ 2.3
c. PRO-2 remission is defined as abdominal pain (AP) mean daily score at or below 1 and stool frequency (SF) mean daily score at or below 3, and no worsening of AP or SF from baseline.11
d. Fatigue response is defined as improvement of ≥ 7 points in PROMIS-Fatigue Short Form 7a.3
e. Endoscopic remission is defined as SES-CD Score ≤ 2.3
ABOUT THE GALAXI PROGRAMME (EudraCT 2017-002195-13)
GALAXI is a treat-through, double-blind, placebo-controlled, active-controlled (ustekinumab), 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 (TNF antagonists, 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).1,3 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.1,3
ABOUT THE GRAVITI Phase 3 study (EudraCT 2020-006165-11)
GRAVITI is a treat-through, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of guselkumab subcutaneous induction therapy in 350 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 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.3
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.6 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.12 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.13 There is currently no cure for Crohn’s disease.14
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-23.5,7,8,9 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.5 It is also approved in the U.S,16 Canada,17 Japan18 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).5
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/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.
CP-508708
March 2025