HORSHAM, Pa. (June 17, 2025) – Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand approval of STELARA® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease (CD). STELARA is currently approved for the treatment of adults living with moderately to severely active CD and ulcerative colitis, in addition to the treatment of adults and children six years and older with active psoriatic arthritis and moderate to severe plaque psoriasis.
The sBLA is supported by data from the Phase 3 UNITI-Jr clinical study, a multicenter, open-label study to evaluate the efficacy, safety, and pharmacokinetics of STELARA for the treatment of pediatric CD through 52 weeks.
“Living with a lifelong condition like Crohn’s disease 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 Crohn’s disease diagnosis continue to struggle,” said Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “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.”
Of the nearly one million people in the U.S. living with CD, approximately up to 25 percent are children and the rate of CD in this younger population continues to rise. Crohn’s disease can be more severe for the pediatric population compared to adults, further highlighting the need for additional treatment options.1,2
Editor’s Notes:
a. STELARA® is not currently approved in the U.S. to treat moderately to severely active pediatric Crohn’s disease (CD)
ABOUT PEDIATRIC CROHN’S DISEASE
Crohn’s disease (CD) is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans.3 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.4 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn’s disease.1 Nearly one million people in the U.S. are living with CD, approximately up to 25 percent of those individuals are pediatric.1
ABOUT THE PHASE 3 UNITI JR STUDY (NCT04673357)
UNITI Jr is a Phase 3, multi-center open-label study evaluating the efficacy, safety, and pharmacokinetics of ustekinumab for the treatment of moderately to severely active Crohn’s disease in pediatric patients two years of age and older.
ABOUT STELARA® (ustekinumab)
STELARA® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is a prescription medicine approved in the United States to treat.
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adults and children 6 years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
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adults and children 6 years and older with active psoriatic arthritis.
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adults 18 years and older with moderately to severely active Crohn’s disease.
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adults 18 years and older with moderately to severely active ulcerative colitis.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Footnotes
1 National Organization for Rare Disorders. Pediatric Crohn’s Disease. Available at: https://rarediseases.org/rarediseases/pediatric-crohns-disease/. Accessed June 2025
2 von Allmen D. (2018). Pediatric Crohn’s Disease. Clinics in colon and rectal surgery, 31(2), 80–88. https://doi.org/10.1055/s-0037-1609022
3 Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed June 2025.
4 Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed June 2025.