Johnson & Johnson announces FDA approval of STELARA (ustekinumab) for children aged ≥2 years with moderately to severely active Crohn’s disease, marking the first non-TNF biologic for pediatric patients
Written By: Pharmacally Medical News Desk
Johnson & Johnson has announced that the U.S. Food and Drug Administration approved STELARA® (ustekinumab) on April 15, 2026, for the treatment of children aged two years and older with moderately to severely active Crohn’s disease. This decision expands the drug’s label into a younger pediatric population with limited treatment options and marks the first non‑TNF biologic approved for pediatric Crohn’s disease in this age group.
The approval is supported by data from the Phase 3 UNITI‑Jr study (NCT04673357), a multicenter, open‑label trial evaluating efficacy, safety, and pharmacokinetics of ustekinumab over 52 weeks, including an 8‑week induction phase followed by a 44‑week maintenance phase. The study showed that the safety profile in pediatric patients was consistent with that observed in adults.
During the induction phase, the most common adverse event reported in at least 10% of patients was upper respiratory tract infection (13%). In the maintenance phase, commonly reported adverse events included upper respiratory tract infection (17%), COVID‑19 (17%), and headache (10%).
STELARA is an interleukin (IL)‑12 and IL‑23 antagonist and remains the only FDA‑approved IL‑12/23 inhibitor across both adult and pediatric populations with Crohn’s disease. The therapy works by targeting these cytokines, thereby helping to reduce intestinal inflammation and disease activity.
As an immune‑modulating biologic, STELARA carries important safety considerations, including risks of serious infections, malignancies, hypersensitivity and allergic‑type reactions, interstitial lung disease, and rare neurological conditions such as posterior reversible encephalopathy syndrome (PRES); careful patient selection and ongoing monitoring are therefore required.
STELARA is already approved in the United States for multiple indications, including moderate‑to‑severe plaque psoriasis and psoriatic arthritis in adults and children aged six years and older, as well as for adult Crohn’s disease and adult ulcerative colitis. This latest approval further strengthens its role across a spectrum of inflammatory diseases.
Crohn’s disease affects nearly one million people in the United States, with up to 25% of cases diagnosed during childhood. Pediatric‑onset disease is often more aggressive, with higher risks of growth impairment and long‑term complications, underscoring the need for expanded treatment options in younger patients.
References
STELARA® Pediatric Crohn’s Disease FDA Approval J&J Statement