Crohn’s disease fourth EC approval for Tremfya

8 May 2025

The European Commission (EC) has approved a Marketing Authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

Tremfya, the first dual-acting interleukin (IL)-23 inhibitor offering both subcutaneous and intravenous induction options, was recently approved by the EC in moderately to severely active ulcerative colitis (UC).

CD and UC are the two main forms of inflammatory bowel disease, which affects more than four million people in Europe, a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases, including CD.

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