Johnson & Johnson Seeks FDA Approval for TREMFYA® in Ulcerative Colitis Treatment

Johnson & Johnson has taken a significant step forward by submitting a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for TREMFYA® (guselkumab) to treat adults experiencing moderately to severely active ulcerative colitis (UC). This submission is based on compelling findings from the Phase 3 QUASAR program, which evaluated the efficacy and safety of TREMFYA® in individuals with UC who had shown inadequate responses or intolerance to conventional therapy, previous biologics, and/or JAK inhibitors.

The data demonstrates statistically significant and clinically meaningful improvements in symptoms, patient-reported outcomes, such as fatigue, and measures of disease activity, including high-bar endpoints like endoscopic and histologic remission. Moreover, the safety profile observed aligns with TREMFYA®'s established safety record in its approved indications.