Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilar Deals 2025
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Helen Macpherson
Intranet
Kimberley Evans
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

New Indication Alert: J&J’s Guselkumab EC Approved for Crohn’s Disease

May 7, 2025

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).