Tremfya (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease

Janssen

25 April 2025 - Johnson & Johnson today announced that the European Commission has approved a Marketing Authorisation for Tremfya (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

The approval is supported by data from the QUASAR programme, which consists of the Phase 2b induction dose-ranging study and the Phase 3 induction and maintenance studies, evaluating the efficacy and safety of guselkumab in adult patients with moderately to severely active UC who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe