J & J Seeks US FDA Approval for Subcutaneous Tremfya in Ulcerative Colitis

Johnson & Johnson seeks US FDA approval for subcutaneous induction regimen of Tremfya in ulcerative colitis

Overview

Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of Tremfya (guselkumab) for the treatment of adults with moderately to severely active UC. The filing is supported by data from the phase 3 ASTRO study of Tremfya SC induction therapy in adults with UC and builds upon the recent US approval of Tremfya in this indication.

The Phase 3 ASTRO Trial

• The phase 3 ASTRO study met its primary endpoint, achieving a statistically significant and clinically meaningful results for clinical remission at Week 12 with a 400 mg SC induction dose of Tremfya administered at Weeks 0, 4, and 8. 
• All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also met. 
• Safety data from ASTRO were consistent with the safety findings from the QUASAR programme. Results from the ASTRO study are planned for presentation at upcoming medical meetings.

From Johnson & Johnson Innovative Medicine

• With the ASTRO study in UC and the GRAVITI study in Crohn's disease (CD), we are focused on delivering versatility and options for administration of treatment for people with inflammatory bowel disease (IBD). 
• Tremfya is the first IL-23 inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers,"" stated Esi Lamousé-Smith, M.D., Ph.D., vice president, gastroenterology disease area lead, immunology, Johnson & Johnson Innovative Medicine. 
• The ASTRO results add to the compelling data generated from the QUASAR programme in UC and build on the promise of Tremfya in the treatment of IBD as we look to transform outcomes for patients.

The First and Only: Tremfya

• Tremfya is the first and only approved, dual-acting 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 UC.
• Tremfya received US FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. 
• The approval was supported by data from the phase 3 QUASAR study evaluating the efficacy and safety of Tremfya in adults with moderately to severely active UC.

An application seeking approval of Tremfya for the treatment of adults with moderately to severely active CD has been submitted in the US, and applications seeking approval for both CD and UC have been submitted in Europe.

The ASTRO Trial

• ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through phase 3 study to evaluate the efficacy and safety of Tremfya 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. 
• Patients were randomized 1:1:1 to receive Tremfya 400 mg SC induction at Weeks 0, 4 and 8 followed by Tremfya 200 mg SC q4w; or Tremfya 400 mg SC induction at Weeks 0, 4 and 8, followed by Tremfya 100 mg SC q8w; or placebo. 
• The maintenance doses in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the phase 3 QUASAR programme that established the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.

About the QUASAR Trial

• QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, phase 2b/3 program designed to evaluate the efficacy and safety of Tremfya 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 JAK inhibitors (tofacitinib). 
• QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a phase 3 randomized withdrawal maintenance study. 
• In the induction study, patients received either Tremfya 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. 
• In the maintenance study, patients received a SC maintenance regimen of either Tremfya 200 mg q4w, Tremfya 100 mg q8w, or placebo.

About GRAVITI

• GRAVITI is a randomized, double-blind, placebo-controlled, treat-through phase 3 study to evaluate the efficacy and safety of Tremfya SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults 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). 
• Patients received Tremfya 400 mg SC at Weeks 0, 4, and 8 followed by Tremfya 200 mg SC q4w; or Tremfya 400 mg SC at Weeks 0, 4, and 8 followed by Tremfya 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).

About Ulcerative Colitis

• Ulcerative colitis (UC) 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. 
• It is the result of the immune system's overactive response. 
• Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.  

About Crohn's Disease

• Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans. 
• 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. 
• Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.

About Tremfya

• Developed by Johnson & Johnson, Tremfya is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). 
• Findings for dual-acting 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: Approvals & Indications

Tremfya Is a Prescription Medicine Approved in the Us to Treat: 

• adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light); 
• adults with active psoriatic arthritis; 
• adults with moderately to severely active ulcerative colitis.
• Tremfya is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.

Johnson & Johnson maintains exclusive worldwide marketing rights to Tremfya.

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