Johnson & Johnson : STELARA® Pediatric Crohn’s Disease FDA Approval J&J Statement

Published: 2026-05-01 16:21:24 ET JNJ

Published on 05/01/2026 at 04:21 pm EDT

On April 15, 2026, the U.S. Food and Drug Administration (FDA) approved STELARA®(ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohn's disease (CD).1

STELARA®(ustekinumab) is the only FDA-approved IL-12/23 antagonist and the first non-TNF biologic to treat adult and pediatric patients two years and older with moderately to severely active Crohn's disease (CD).

Nearly one million people in the U.S. live with Crohn's disease, with up to 25% diagnosed during childhood.³ In the pediatric population, the disease is often more aggressive, increasing the risk of growth impairment and lifelong complications during critical developmental years, and approved pediatric treatment options remain limited.³⁻⁴ This approval marks the first non-TNF biologic approved for pediatric patients two years and older with moderately to severely active Crohn's disease.

The approval is based on data from the Phase 3 UNITI-Jr clinical study, a multicenter interventional study to evaluate the efficacy, safety, and pharmacokinetics of STELARA®(ustekinumab) for the treatment of pediatric CD over 52 weeks (8 weeks of induction and 44 weeks of maintenance).2 The adverse reaction profile in these pediatric subjects was similar to that reported in adult clinical trials in patients with Crohn's disease. In the Crohn's disease induction phase in pediatric patients treated with STELARA, the most common adverse reaction (at least 10% of pediatric patients) was upper respiratory tract infection (13%). In the Crohn's disease maintenance phase in pediatric patients treated with STELARA, common adverse reactions (at least 10% of pediatric patients) were upper respiratory tract infection (17%), COVID-19 (17%), and headache (10%).

Selected Important Safety Information

STELARA®is not for everyone; only your doctor can decide ifthey'reright for you. STELARA®is a prescription medicine that affects your immune system. STELARA®can increase your chances of having serious side effects including serious infections, cancer, serious allergic reactions, lung inflammation, and rare conditions-posterior reversible encephalopathy syndrome. Talk to your doctor if you need a vaccine. Please read theImportant Safety Information, theMedication Guide, and the fullPrescribing Information for STELARA® to learn more about these and other risks. Discuss any questions you have with your doctor.

ABOUT THE PHASE3 UNITI JR STUDY (NCT04673357) UNITI Jr is a Phase 3, multicenter 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 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.5 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.6 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.3 Nearly one million people in the U.S. are living with CD; up to 25% of those individuals are pediatric.3 Crohn's disease can be more severe for the pediatric population compared to adults, further highlighting the need for additional treatment options.3,4

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:

The Janssen Pharmaceutical Companies of Johnson & Johnsonmaintainexclusive worldwide marketing rights to STELARA®.

Cautions Concerning Forward-Looking Statements Thisstatementcontains"forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding STELARA®(ustekinumab).The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertaintiesmaterialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statementas aresult ofnewinformationorfuture events or developments.

Footnotes 1STELARA®Pediatrics CD FDA Approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761044Orig1s020,%20125261Orig1s172ltr.pdfAccessedApril2026. 2ClinicalTrials.govAbout Phase3 UNITI-Jr clinical study (NCT04673357). https://clinicaltrials.gov/study/NCT04673357 AccessedApril2026. 3NationalOrganization for Rare Disorders. Pediatric Crohn's Disease. Available at:https://rarediseases.org/rarediseases/pediatric-crohns-disease/ Accessed April 2026. 4von 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. AccessedApril2026. 5Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at:https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview Accessed April 2026. 6Crohn's & Colitis Foundation. What is Crohn's disease? Available at:https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes Accessed April 2026. 7Mitchel EB, Rosh JR. Pediatric Management of Crohn's Disease. Gastroenterology ClinicsofNorth America. 2022;51(2):401-424. PMID: 35595422.https://pubmed.ncbi.nlm.nih.gov/35595422/ AccessedApril2026.

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Johnson & Johnson published this content on May 01, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 01, 2026 at 20:20 UTC.