Families managing a child's ulcerative colitis gained a treatment option last week that did not exist for them before. The Food and Drug Administration approved Stelara for moderately to severely active ulcerative colitis in patients aged 2 years and older on Aug. 28.
Until now, the advanced therapies formally labeled for children with moderate to severe ulcerative colitis all targeted tumor necrosis factor. Not every child responds to that class, and some who do lose response over time. Parents in that position have generally faced off-label prescribing, insurance appeals, or both.