Johnson & Johnson announced FDA approval of TREMFYA® (guselkumab) for treating moderately to severely active ulcerative colitis (UC) in adults. TREMFYA® is the first fully-human monoclonal antibody that blocks IL-23 and binds to CD64, showing significant improvements in UC symptoms and endoscopic healing. The approval is based on data from the QUASAR Phase 2b/3 study, which highlighted the drug’s efficacy in patients unresponsive to other treatments.
FDA approves Johnson & Johnson’s TREMFYA for ulcerative colitis (Pharmaceutical Technology)
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