European Commission approves Johnson & Johnson’s Crohn’s disease therapy
Ella Day | May 12, 2025 | News story | Market Access, Research and Development, Sales and Marketing | Crohn’s disease, European Commission, Gastrointestinal tract, Johnson & Johnson, guselkumab, marketing authorisation
The European Commission (EC) has granted Marketing Authorisation (MA) to Johnson & Johnson’s Tremfya (guselkumab) for the treatment of moderately to severely active Crohn’s disease (CD) in adults. The decision follows positive results from two phase 3 programmes, GALAXI and GRAVITI, demonstrating guselkumab’s efficacy and safety.
Guselkumab became the first approved fully human, dual acting IL-23p19 subunit inhibitor, offering both intravenous and subcutaneous induction regimens. IL-23 is a cytokine which is understood to be responsible for immune-mediated diseases such as CD. This approval provides a new treatment option for patients who have not responded to, lost response to, or were intolerant of conventional or biologic therapies.
Both of the studies demonstrated efficacy of guselkumab in achieving clinical and endoscopic endpoints. Safety outcomes remained consistent with previous indications for guselkumab in other immune-mediated conditions.
This agreement follows the recent EC approval of guselkumab in moderately to severely active ulcerative colitis (UC) and marks the fourth EU indication for guselkumab, following previous approvals for psoriasis, psoriatic arthritis and UC.
Senior director at Johnson & Johnson Innovative Medicine EMEA , Mark Graham, commented: “Guselkumab provides people living with CD and healthcare professionals a new treatment option that is supported by data from multiple phase 3 studies.”
Ella Day
12/5/25
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