Posted by Michael Wonder on 23 Dec 2018
Janssen submits application to U.S. FDA seeking approval of Stelara (ustekinumab) for treatment of moderately to severely active ulcerative colitis
20 December 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental biologics license application to the U.S. FDA seeking approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis.
Stelara is the first and only biologic targeting interleukin (IL)-12 and IL-23 cytokines, which evidence suggests play an important role in inflammation associated with auto-immune conditions, such as ulcerative colitis. Stelara is approved in many countries, including the U.S., for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis and moderate to severe Crohn's disease.
The submission is based on data from the Phase 3 UNIFI global clinical development program, which included two studies (one induction and one maintenance study) evaluating the efficacy and safety of Stelara for the treatment of moderately to severely active ulcerative colitis in adults.
