A long-awaited approval for an advanced pediatric IBD treatment!

The European Medicines Agency (EMA) recently adopted a positive opinion extending the use of Stelara (ustekinumab) for children with Crohn’s disease who weigh at least 40kg.

Why is this important?

  • It marks another step forward in improving treatment options for young people living with IBD.

  • Paediatric patients will now have an on-label treatment option, reducing the need for off-label drug use.

  • This improves safety and efficacy, ensuring children receive the best possible care.

More information: 

https://www.ema.europa.eu/en/medicines/human/variation/stelara

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EFCCA Magazine 1/2025