On 7 May 2025, Johnson & Johnson announced that the European Commission (EC) has approved Tremfya® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
This follows the recent EU approval of Tremfya® in April 2025 for the treatment of 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.
In March 2025, Tremfya® was approved by the US FDA for adult patients with moderately to severely active Crohn’s disease. Tremfya® is also approved in the US for a number of other indications, including for ulcerative colitis (September 2024) and plaque psoriasis (July 2017).