Johnson & Johnson seek FDA approval for TREMFYA in ulcerative colitis

Johnson & Johnson announce the submission of their SBLA to the U.S. FDA seeking approval of a subcutaneous induction regimen of TREMFYA 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.

“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 program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients.”

Note that, 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.

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Related Topics and Keywords

FDA, IL-23 inhibitor, Johnson and Johnson, Phase 3 trial, TREMFYA®, TREMFYA® (guselkumab)