Article · Health news

FDA approves Stelara for children with colitis

Health news Published · sources checked

The US FDA approved Stelara (ustekinumab) for children aged 2 and older with moderately to severely active ulcerative colitis, in August 2026.

Key points

  • The US FDA approved Stelara (ustekinumab) injection for paediatric ulcerative colitis in August 2026.
  • It covers patients aged 2 years and older with moderately to severely active disease.
  • The FDA says Stelara is the first approved monoclonal antibody not targeting TNF alpha for the two main forms of paediatric inflammatory bowel disease.
  • This is a US decision; UK availability is decided separately.

What was announced

The US Food and Drug Administration (FDA) approved Stelara (ustekinumab) injection for moderately to severely active ulcerative colitis in patients aged 2 years and older.

The FDA's orphan drug database lists the marketing approval date for this use as 28 August 2026.

The FDA says Stelara was approved on 15 April 2026 for moderately to severely active Crohn's disease in patients aged 2 years and older.

What it means

The FDA says Stelara is the first approved therapeutic monoclonal antibody that does not target TNF alpha for the two main forms of paediatric inflammatory bowel disease.

The FDA lists the most common adverse reactions in children with ulcerative colitis as nasopharyngitis (a common cold), headache, abdominal pain, influenza, fever, diarrhoea, sinusitis, fatigue and nausea.

Stelara has orphan drug designation for this use.

This is a US decision; availability in the UK is decided separately by the MHRA and NICE.

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