Cure8 news brief
This EC approval means ustekinumab (Stelara) is now an authorised treatment option in the EU for certain children and adolescents with moderate–severe Crohn’s disease who have not responded to other treatments.
It may affect treatment choices for paediatric patients and families and is relevant to clinicians prescribing biologics.
Pediatric patients with Crohn’s disease and their parents/caregivers, gastroenterology clinicians treating paediatric IBD, and patients currently using or considering biologic therapy.
The European Commission has approved Stelara (ustekinumab) for treating moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg who have not responded to or cannot tolerate conventional or biologic therapy.
The decision was based on late-stage trial data (UNITI-Jr) and supporting real-world evidence (REALITI) reported by the company. Trial results cited in the source included clinical remission and endoscopic response rates at multiple timepoints; the article also notes the EC decision followed a positive recommendation from the EMA committee.
The story mentions a separate regulatory recommendation for Tremfya (guselkumab) in adults with Crohn’s disease. If you are a caregiver or clinician for a child with Crohn’s disease, this expands an approved biologic option for certain paediatric patients in the EU.
Discussing eligibility, dosing, and potential benefits or risks with a treating specialist is the next appropriate step—this article reports regulatory approval and trial outcomes but does not provide individualized medical advice.
The article summarizes regulatory and trial results reported by the company and EMA committee recommendations. The approval is supported by the UNITI-Jr trial and REALITI real-world data; readers should note trial details, safety data, and official prescribing information will guide clinical use. This is a regulatory update, not treatment guidance.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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