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news.Johnson & Johnson has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) to extend the use of the human interleukin (IL)-12 and IL-23 antagonist, Stelara (ustekinumab), for paediatric patients aged two and above with moderately to severely active Crohn's disease (CD).
CD is said to be a chronic inflammatory condition of the gastrointestinal tract. Credit: derneuemann on Pixabay.
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The application is underpinned by the multi-centre, open-label Phase III UNITI-Jr clinical trial data, which assessed the therapy’s safety, pharmacokinetics, and efficacy in paediatric subjects.
At present, Stelara has received regulatory approval for use in adults with moderately to severely active CD and ulcerative colitis.
It is also approved to treat active psoriatic arthritis in the adult and paediatric population aged six and above, as well as for treating moderate to severe plaque psoriasis in this age group.
CD is said to be a chronic inflammatory condition of the gastrointestinal tract with a complex aetiology involving immune system abnormalities, which may be influenced by genetic, dietary, or environmental factors.
The company noted that in the US, there are around one million individuals with CD, and children constitute up to 25% of this group. Additionally, CD tends to manifest more aggressively in children than in adults.
Johnson & Johnson’s Janssen Pharmaceutical Companies hold exclusive global marketing rights to the therapy.
Johnson & Johnson Innovative Medicine Gastroenterology & Autoantibody Medical Affairs vice president Chris Gasink said: “Living with a lifelong condition like CD can be incredibly challenging, especially for children and adolescents who may experience more severe symptoms and faster disease progression than adults. With limited approved treatment options to support the specific needs of this patient population, many children with a CD diagnosis continue to struggle.
“With the well-established efficacy and safety profile of Stelara in existing indications, this submission aims to better support these patients, their families, and providers with a new treatment option.”
