Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. 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 U.S. approval of TREMFYA in this indication.
 
The Phase 3 ASTRO 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 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 program.
 
“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,” said 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 program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients.”
 
TREMFYA is a 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 U.S. 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.
 
An application seeking approval of TREMFYA for the treatment of adults with moderately to severely active CD has been submitted in the U.S., and applications seeking approval for both CD and UC have been submitted in Europe.