Johnson & Johnson has revealed that it has filed a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA), aiming for the endorsement of a subcutaneous (SC) induction treatment using Tremfya (guselkumab) for adults experiencing moderate to severe ulcerative colitis (UC). This proposal is bolstered by data from the phase 3 ASTRO trial assessing Tremfya SC induction therapy in UC patients and builds on the recent US approval for this indication.
In the phase 3 ASTRO trial, the primary endpoint was achieved, demonstrating statistically significant and clinically meaningful clinical remission results at Week 12 with a 400 mg SC induction dose of Tremfya administered at Weeks 0, 4, and 8. All secondary endpoints, which include endoscopic enhancement and histologic-endoscopic mucosal improvement (HEMI), were successfully met. Safety outcomes from ASTRO were aligned with the safety observations from the QUASAR program. The ASTRO study’s findings are set to be showcased at forthcoming medical conferences.
“Our focus with the ASTRO study in UC and the GRAVITI trial in Crohn’s disease (CD) is on offering flexible and convenient treatment options for individuals affected by inflammatory bowel disease (IBD). Tremfya leads as the first IL-23 inhibitor that could provide a completely SC induction and maintenance regimen, which, upon approval, can simplify decision-making for patients and healthcare providers,” commented Esi Lamouse-Smith, M.D., Ph.D., vice president, gastroenterology disease area lead, immunology, at Johnson & Johnson Innovative Medicine. “The ASTRO results enrich the compelling data from the QUASAR program in UC and advance Tremfya’s promise in IBD treatment, as we aim to revolutionize patient outcomes.”
Tremfya is unparalleled as the only approved, dual-functioning monoclonal antibody that simultaneously blocks IL-23 and targets CD64, a receptor on cells producing IL-23. IL-23 is a cytokine released by activated monocytes/macrophages and dendritic cells known to drive immune-mediated conditions, including UC.
Approval for Tremfya by the US FDA for adult patients with moderate to severe UC was granted in September 2024. This approval supports a protocol involving an initial IV induction, followed by an SC maintenance regimen, underpinned by insights from the phase 3 QUASAR study examining Tremfya’s effectiveness and safety in adults with moderate to severe UC.
Additionally, an application seeking Tremfya’s approval for treating adults with CD is under consideration in the US, alongside parallel applications for both CD and UC in Europe.
The ASTRO trial is a randomized, double-blind, placebo-controlled, parallel-group, multi-center, phase 3 study evaluating Tremfya SC induction therapy’s efficacy and safety (400 mg at Weeks 0, 4, and 8) among adults with moderate to severely active ulcerative colitis, who haven’t adequately responded to or tolerated conventional treatments or previous biologics (e.g., TNF antagonists or vedolizumab).
The QUASAR program incorporated a randomized, double-blind, placebo-controlled, parallel-group, multi-center, phase 2b/3 program to assess Tremfya’s safety and effectiveness in adults with moderate to severe UC who displayed insufficiency or intolerance to standard treatments.
The GRAVITI trial is a randomized, double-blind, placebo-controlled, treat-through phase 3 study to determine Tremfya SC induction therapy’s safety and efficacy in adults with CD facing inadequate responses to existing therapies.
Ulcerative colitis (UC) is a persistent disease affecting the colon’s lining where inflammation and small ulcers develop, leading to various symptoms such as diarrhea, abdominal discomfort, and fatigue.
Crohn’s disease, a major form of inflammatory bowel disease, is a chronic inflammation of the gastrointestinal tract impacting millions, with symptoms ranging from abdominal pain to fever.
Developed by Johnson & Johnson, Tremfya is a pioneering, dual-acting monoclonal antibody intended to intercept inflammation by inhibiting IL-23 and liaising with CD64. Laboratory studies highlight Tremfya’s binding with CD64, integral to inflammation, but the clinical impact remains undetermined.
Tremfya is approved in the United States to treat adults with moderate to severe plaque psoriasis requiring systemic therapy or phototherapy and active psoriatic arthritis or moderate to severely active ulcerative colitis.
In addition to its approval in the US, Tremfya has garnered recognition in Europe, Canada, and Japan for treating adults with severe plaque psoriasis and active psoriatic arthritis.
Johnson & Johnson holds exclusive global marketing rights for Tremfya.