Janssen has submitted an application to the European Medicines Agency (EMA) seeking approval of Stelara for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
Stelara (ustekinumab) is a human monoclonal antibody that targets the interleukin (IL)-12 and IL-23 cytokines – believed to play an important role in the immune and inflammatory responses seen in immune-mediated diseases, such as UC and Crohn’s disease.
This submission follows a supplemental Biologics License Application (sBLA) made to the US FDA on December 20 2018, which also seeks approval of ustekinumab for the treatment of adults with moderately to severely active UC.
The submission is based on data from the Phase 3 UNIFI global clinical development programme, which includes two studies (one induction and one maintenance study) evaluating the efficacy and safety of ustekinumab for the treatment of moderately to severely active UC in adults.
Data indicated that treatment with a single intravenous dose of ustekinumab induces clinical remission and response in adults with moderately to severely active UC who previously experienced an inadequate response or intolerance to conventional or biologic therapies.
If approved, Stelara will be the first interleukin (IL)-12/23 inhibitor licensed for the treatment of ulcerative colitis.