for Pediatric Crohn's disease (ages 2 and older)
FDA approved ustekinumab (Stelara) for patients aged two years and older with moderately to severely active Crohn's disease — pediatric label expansion of an already-marketed biologic.
Crohn's disease is a chronic inflammatory condition that can affect any part of the digestive tract, causing abdominal pain, severe diarrhea, and fatigue. Stelara (ustekinumab) is an antibody that blocks two specific proteins, IL-12 and IL-23, which are key drivers of inflammation. By quieting this immune overactivity, the drug may help control the disruptive symptoms of the disease in children and adolescents.