EU approves Stelara (ustekinumab) for adults with moderately to severely active Crohn's disease- Janssen

Janssen-Cilag International has announced that the European Commission has approved the use of Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF alpha) antagonist or have medical contraindications to such therapies. The EC approval is based on data from three pivotal Phase III trials which included approximately 1,400 patients with moderately to severely active Crohn’s disease.

The studies showed that treatment with Stelara induced clinical response and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active Crohn’s disease after one year of therapy compared to placebo.

Comment: Stelara is the first biologic therapy for Crohn’s disease targeting interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses.