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J&J Indication Expansion for Tremfya® (guselkumab)

May 1, 2024

On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.  This follows news of its US sBLA submission on 11 March 2024 for guselkumab for the treatment of moderately to severely active ulcerative colitis.

Tremfya® (guselkumab) is approved in Europe for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.