EU Approves Tremfya In Third Indication, Ulcerative Colitis

 
• By Sushmita Panda

J&J secures EU approval for its IL-23 inhibitor Tremfya for ulcerative colitis, its third indication in the region, amid strong competition in the sector. EU approval is also awaited for Crohn’s disease.

J&J building
Developed by Johnson & Johnson, guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. • Source: Shutterstock

Johnson & Johnson’s blockbuster psoriasis drug Tremfya (guselkumab) has received approval from the European Commission (EC) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), marking its third indication in the European Union.

Guselkumab first received approval in the EU in November 2017 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. The dual-acting IL-23p19 subunit inhibitor...

Key Takeaways
  • J&J's Tremfya has been approved for moderately to severely active ulcerative colitis in the EU.
  • Approval was supported by data from...

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