Johnson & Johnson (JNJ) has submitted a new application to the U.S. FDA to expand the use of Stelara (ustekinumab) for treating children aged two and older with moderate to severe ulcerative colitis.
This application is backed by results from the Phase 3 UNIFI Jr clinical trial.
Currently, Stelara is approved for adults with moderate to severe Crohn’s disease and ulcerative colitis, as well as for adults and children aged six and older with active psoriatic arthritis and moderate to severe plaque psoriasis.
