pmlive.com
J&J’s Stelara granted EC approval to treat Crohn’s disease in paediatric patients
Regulatory approval means ustekinumab (Stelara) can now be prescribed in the EU for some children with moderate‑to‑severe Crohn’s disease who haven’t responded to other treatments. This expands treatment options for pediatric IBD and is based on clinical trial and real‑world evidence.
Pediatric patients with moderate‑to‑severe Crohn’s disease and their caregivers, pediatric gastroenterologists, clinicians managing children on biologics, and IBD researchers tracking pediatric approvals.
What To Know
The European Commission has approved Stelara (ustekinumab) for moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, based on late-stage UNITI-Jr trial results and supporting real-world data.
The article reports remission and endoscopic response rates from the trial and notes the approval follows an EMA committee recommendation. It also mentions a separate EMA recommendation for Tremfya (guselkumab) in adult Crohn’s disease.
Stelara is described as an antibody targeting interleukin‑12 and interleukin‑23; the approval covers children/adolescents with inadequate response or intolerance to conventional or biologic therapy. The published trial outcomes and the REALITI real‑world study are cited as evidence used by regulators.
This is a regulatory approval notice rather than new treatment guidance. If you or a child you care for might be affected, talk with your pediatric gastroenterology team about whether this option applies, eligibility criteria (including the 40 kg weight threshold), and how it fits with prior treatments.
For clinicians and researchers, the article may be a prompt to review the UNITI‑Jr data and real‑world evidence cited to understand the magnitude and durability of benefit reported.
This report is a regulatory update citing UNITI‑Jr trial results and real‑world data; it does not provide full trial methods or safety details. Approval applies only to patients meeting the stated criteria (including weight ≥40 kg).
The article also mentions a separate EMA recommendation for guselkumab in adults; that is a related regulatory development but distinct from the paediatric ustekinumab approval.