Health Canada authorizes TREMFYA® (guselkumab), the first and only dual-binding IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease

• Supported by the data from the GALAXI program and GRAVITI study, TREMFYA® is the only IL-23i to demonstrate clinical remission and endoscopic response, both at one year, with a fully subcutaneous induction regimen
• Supported by data from the GALAXI study, TREMFYA® is the only IL-23i to show superiority versus STELARA® in all pooled endoscopic endpoints within a double-blinded registrational trial
• The authorization of TREMFYA® in Crohn’s disease is the third indication for this dual-binding IL-23i in Canada

TORONTO, July 31, 2025 – Johnson & Johnson (NYSE: JNJ) today announced that Health Canada has issued a Notice of Compliance (NOC) for TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract which impacts the lives of 164,000 Canadians.^i,ii,iii TREMFYA® is the first and only approved fully-human, dual-binding monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. 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 CD.^{iv,v,i,vi,vii}

“Despite progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” said Remo Panaccione, MD, FRCPC, Professor of Medicine and Director of the Inflammatory Bowel Disease Unit at the University of Calgary and lead investigator of the Phase 3 GRAVITI study. “The approval of TREMFYA offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before with IL-23 inhibitors.”

This approval is supported by results from multiple rigorous Phase 3 trials evaluating more than 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy (i.e. corticosteroids or immunomodulators) or biologics.ⁱ The GALAXI study evaluated TREMFYA® I.V. induction and subcutaneous maintenance versus placebo. The data demonstrated a benefit in the co-primary endpoints and the clinical program showed TREMFYA® was superior to STELARA® in all pooled endoscopic endpoints, the only IL-23 inhibitor to achieve this in a double-blinded registrational program. The GRAVITI study evaluated subcutaneous TREMFYA® induction and maintenance therapy versus placebo. The comprehensive results from these Phase 3 studies demonstrated the efficacy of subcutaneous TREMFYA® or TREMFYA® I.V. in achieving clinical and endoscopic endpoints. Highlights from these pivotal studies showed:

“Crohn’s disease is a complex autoimmune disease that can significantly impact a person’s quality of life, including their ability to engage in daily activities such as work, school and social engagements,” said Sylvain Chiasson, Interim President & CEO of Crohn’s and Colitis Canada. “Because of the unpredictability of the disease, people with Crohn’s are two to four times more likely to experience anxiety and depression. No two Crohn’s patients experience their disease the same way, and this also goes for treatments. So, the Canadian authorization of TREMFYA is most welcome news for Canadians with Crohn’s.”

TREMFYA® dosing in the treatment of moderately to severely active CD:ⁱ

• Induction:
  The recommended induction dosage is:

  200 mg of TREMFYA® I.V. administered by intravenous infusion over a period of at least one hour at Week 0, Week 4 and Week 8.

  Or

  400 mg of TREMFYA® administered by subcutaneous injection at Week 0, Week 4 and Week 8. Each 400 mg dose is given as two injections of 200 mg.

• Maintenance:
  The recommended maintenance dosage is 100 mg of TREMFYA® administered by subcutaneous injection at Week 16 and every 8 weeks thereafter.

  A dose of 200 mg administered by subcutaneous injection at Week 12 and every 4 weeks thereafter may be considered for patients who do not show adequate therapeutic benefit to guselkumab, or according to clinical judgement.

“We are pleased to announce the authorization of TREMFYA®, the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active Crohn’s disease in Canada,” said Alexander Henderson, Vice President, Medical Affairs, Johnson & Johnson Innovative Medicine, Canada. “This treatment provides a new opportunity for people living with Crohn’s disease to obtain significant improvements in clinical and endoscopic outcomes with the convenience of self-administration from the outset. TREMFYA® is supported by data from multiple Phase 3 studies and is the only IL-23 inhibitor to demonstrate superiority to STELARA® in a double-blinded registrational trial.”

Johnson & Johnson is committed to enabling access to all its treatments, including by operating a patient support program which offers reimbursement navigation support, called J&J BioAdvance.

This NOC marks the third indication for TREMFYA® in Canada, following moderate- to severe plaque psoriasis in November 2017, and active psoriatic arthritis in September 2020,⁶ underscoring Johnson & Johnson’s long-standing legacy of innovation and commitment to patients living with chronic immune-mediated diseases, including IBD.

ABOUT THE GALAXI PROGRAM (NCT03466411)
GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program 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 (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab).^viii GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).^ii,iv Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years. Patients received guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg subcutaneous maintenance every 4 weeks; or guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg subcutaneous maintenance every 8 weeks; or a biologic active control; or placebo. Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. Of the 873 individuals pooled across the GALAXI 2 & 3 dataset, 456 (52 per cent) had prior history of inadequate response to biologics, 365 (42 per cent) were biologic-naïve and 52 (6 per cent) were biologic experienced without documented inadequate response or intolerance. The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in Crohn’s disease, showing guselkumab was superior to ustekinumab in all endoscopic-based endpoints when analyzed with pooled data.

ABOUT THE GRAVITI STUDY (NCT05197049)
GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in patients with moderately to severely active Crohn’s disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab).^ix Patients received guselkumab 400 mg SC q4w (x3) followed by guselkumab 200 mg SC q4w; or guselkumab 400 mg SC q4w (x3) followed by guselkumab 100 mg SC q8w; or placebo. The maintenance doses in GRAVITI (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 GALAXI 2 and GALAXI 3 studies that evaluated the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active Crohn’s disease. Similarly to GALAXI, GRAVITI employed a treat-through design, in which patients were randomized to guselkumab at Week 0 and remained on that regimen throughout the study, regardless of clinical response status at the end of induction. Participants randomized to placebo were able to receive guselkumab (400 mg SC q4w x3 ➔ 100 mg SC q8w) if rescue criteria were met at Week 16.^ix

ABOUT CROHN’S DISEASE
The prevalence of Inflammatory bowel disease (including Crohn’s disease and Colitis) in Canada continues to increase with a projected impact of 1 in 91 or 1.1% of the population by 2035.^x 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.^xi Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn’s disease.^xii

ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-binding monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-binding are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23-producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.

TREMFYA® (guselkumab injection) is a prescription medicine authorized in Canada forⁱ:

• The treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
• The treatment of adult patients with active psoriatic arthritis.

TREMFYA®/TREMFYA I.V.® (guselkumab injection/guselkumab for injection) is indicated for:

• The treatment of adult patients with moderate to severely active Crohn’s disease.

TREMFYA® can be used alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

TREMFYA® is approved in The United States, Europe and a number of other countries for the treatment of adults with moderate- to severe plaque psoriasis, for the treatment of adults with active psoriatic arthritis and for the treatment of moderate to severe Crohn’s disease.

Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®.

ABOUT STELARA® (ustekinumab)
STELARA® (ustekinumab) is a human interleukin (IL)-12 and IL-23 antagonist indicated for the treatment of^xiii:

Adult patients with:

• Chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
• Active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate.
• (STELARA®/STELARA® I.V.) Moderately to severely active Crohn’s disease, who have an inadequate response, loss of response to, or were intolerant to either immunomodulators or one of more tumour necrosis factor-alpha (TNFa) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids.
  

Pediatric patients 12-17 years of age with:

Chronic moderate to severe plaque psoriasis who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Johnson & Johnson maintains exclusive worldwide marketing rights to STELARA®.

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 https://www.jnj.com and https://innovativemedicine.jnj.com/canada. Follow us on LinkedIn at Johnson & Johnson Innovative Medicine, Canada. Janssen Inc. is a Johnson & Johnson company.

Media contact:
Alana Vineberg
avineber@its.jnj.com
647-354-8787

Investor contact:
Lauren Johnson
investor-relations@its.jnj.com

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 materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV 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 Research & Development, LLC, Janssen Scientific Affairs, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

*Dr. Panaccione has not been compensated for this media work. Dr. Panaccione is a paid consultant for Johnson & Johnson.

**Spokesperson for Crohn’s and Colitis Canada has not received compensation from J&J. The company has provided funding to Crohn’s and Colitis Canada for other initiatives.

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