Johnson & Johnson Advances Ulcerative Colitis Treatment with FDA Filing for TREMFYA® Subcutaneous Regimen

Johnson & Johnson

SPRING HOUSE, PA – Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC). This move builds on the recent FDA approval of TREMFYA® for the condition and could make it the first IL-23 inhibitor to offer both subcutaneous and intravenous induction options for UC.

The submission is supported by promising results from the Phase 3 ASTRO study, which met its primary goal of clinical remission at Week 12 with a SC induction dose of 400 mg administered at Weeks 0, 4, and 8. Secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also achieved. Safety profiles observed in ASTRO were consistent with findings from the QUASAR program, which previously established the efficacy of TREMFYA®’s intravenous induction followed by subcutaneous maintenance therapy.

“TREMFYA® continues to demonstrate its potential to transform inflammatory bowel disease treatment by offering versatile options for both patients and providers,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President and Gastroenterology Disease Area Lead at Johnson & Johnson Innovative Medicine. She highlighted how the new subcutaneous regimen could provide greater simplicity and flexibility for those managing UC.

TREMFYA® is a dual-acting monoclonal antibody that targets IL-23, a key driver of immune-mediated diseases like UC. This innovation aims to reduce inflammation at the cellular level to improve outcomes for patients. If approved, the SC induction regimen would enhance treatment options for those who require alternatives to conventional UC therapies or have not responded adequately to previous biologic treatments.

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Ulcerative colitis is a chronic and painful condition affecting the lining of the colon, causing inflammation, bleeding, and other debilitating symptoms. Johnson & Johnson remains committed to advancing therapies like TREMFYA® to improve care for patients and address the growing demand for individualized treatment approaches.

The findings from the ASTRO study will be presented at future medical meetings, further contributing to the body of research supporting TREMFYA®’s role in addressing chronic inflammatory diseases.

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