J&J Submits sBLA for Guselkumab (Tremfya) Subcutaneous Induction Regimen in UC

Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) seeking approval of a subcutaneous (SC) induction regimen of guselkumab (Tremfya) for the treatment of adults with moderately to severely active ulcerative colitis (UC).¹

According to a November 22, 2024, press release, the filing is supported by data from the phase 3 ASTRO study of guselkumab SC induction therapy in adults with UC and builds upon the recent US Food and Drug Administration (FDA) approval of guselkumab for this indication.^1,2

"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," Esi Lamousé-Smith, MD, PhD, vice president, gastroenterology disease area lead, immunology, at Johnson & Johnson Innovative Medicine, said in a press release.¹ "The ASTRO results add to the compelling data generated from the QUASAR program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients."

Guselkumab is the first approved fully human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking interleukin (IL)-23 and binding to CD64, a receptor on the cell that produces IL-23. It earned FDA approval for the treatment of UC on September 11, 2024, based on data from the ongoing phase 2b/3 QUASAR study demonstrating guselkumab’s ability to induce clinical and endoscopic remission in adult patients with moderately to severely active UC who experienced an inadequate response or who demonstrate intolerance to conventional therapy, other biologics and/or JAK inhibitors.¹

In addition to its approval in UC, guselkumab is also currently indicated for the treatment of 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) as well as adults with active psoriatic arthritis.¹

Currently, guselkumab is approved for UC as a a 200 mg induction dose administered intravenously at weeks 0, 4, and 8 by a healthcare professional, followed by a recommended maintenance dosage of 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter.¹

The sBLA seeking approval for a SC induction regimen is based on data from the randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through phase 3 ASTRO study evaluating the efficacy and safety of guselkumab SC induction therapy (400 mg at weeks 0, 4, and 8) in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics, and/or ozanimod or approved JAK inhibitors.¹

In the study, patients were randomly assigned in a 1:1:1 ratio to receive 1 of the following:

• Guselukmab 400 mg SC induction at weeks 0, 4, and 8 followed by guselkumab 200 mg SC q4w
• Guselkumab 400 mg SC induction at weeks 0, 4 and 8, followed by guselkumab 100 mg SC q8w

Of note, the study met its primary endpoint, achieving statistically significant and clinically meaningful results for clinical remission at week 12 with a 400 mg SC induction dose of guselkumab administered at weeks 0, 4, and 8. All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement, were also met, and safety data from ASTRO were consistent with the safety findings from the QUASAR program.¹

According to a release from Johnson & Johnson, results from the ASTRO study are planned for presentation at upcoming medical meetings.¹

References

1. ^{Johnson & Johnson. Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA® (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor. November 22, 2024. Accessed November 22, 2024. https://www.prnewswire.com/news-releases/johnson--johnson-seeks-us-fda-approval-for-subcutaneous-induction-regimen-of-tremfya-guselkumab-in-ulcerative-colitis-a-first-for-an-il-23-inhibitor-302313913.html}
2. ^{Brooks, A. FDA Approves Guselkumab (Tremfya) for Ulcerative Colitis. HCPLive. September 11, 2024. Accessed November 22, 2024. https://www.hcplive.com/view/fda-approves-guselkumab-tremfya-for-ulcerative-colitis}