BRIEF—FDA approves Stelara for ulcerative colitis

Johnson & Johnson subsidiary Janssen today announced the US Food and Drug Administration’s approval of Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

UC is a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, affecting around 910,000 people in the USA. Stelara is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines.

The approval for this new indication is based on results from the pivotal Phase III UNIFI clinical trial program which demonstrated that treatment with Stelara both induced and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active ulcerative colitis compared to placebo, the study’s primary endpoints. Stelara is the first and only treatment for UC approved to provide improvement of the colon based on a novel histologic-endoscopic mucosal improvement endpoint.