Johnson & Johnson Announces FDA Approval of STELARA® for Pediatric Crohn’s Disease

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%).

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:

• 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).
• adults and children 6 years and older with active psoriatic arthritis.
• adults 18 years and older with moderately to severely active Crohn’s disease.
• pediatric patients 2 years of age and older with moderately to severely active Crohn’s disease.
• 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^®.

IMPORTANT SAFETY INFORMATION

STELARA and Ustekinumab are prescription medicines that affect your immune system. STELARA and Ustekinumab can increase your chance of having serious side effects, including:

Serious Infections
STELARA and Ustekinumab may lower your ability to fight infections and may increase your risk of infections. Some people have serious infections during treatment with STELARA or Ustekinumab, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

• Your healthcare provider should check you for TB before starting STELARA or Ustekinumab and watch you closely for signs and symptoms of TB during treatment with STELARA or Ustekinumab.
• If your healthcare provider feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA or Ustekinumab

You should not start STELARA or Ustekinumab if you have any kind of infection unless your healthcare provider says it is okay.

Before starting STELARA or Ustekinumab, tell your healthcare provider if you:

• think you have an infection or have symptoms of an infection such as:
  
  • fever, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feel very tired
• are being treated for an infection or have any open cuts.
• get a lot of infections or have infections that keep coming back.
• have TB, or have been in close contact with someone with TB.

After starting STELARA or Ustekinumab, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA and Ustekinumab can make you more likely to get infections or make an infection that you have worse.

People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA or Ustekinumab may also be more likely to get these infections.

Cancers
STELARA and Ustekinumab may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your healthcare provider if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving either STELARA or Ustekinumab. Tell your healthcare provider if you have any new skin growths.

Serious Allergic Reactions
Serious allergic reactions including death can occur. Stop using STELARA or Ustekinumab and get medical help right away if you get any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest discomfort, trouble breathing, or skin rash.

Posterior Reversible Encephalopathy Syndrome (PRES)
PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if you get any symptoms of PRES during treatment with STELARA, including: headache, seizures, confusion, and vision problems.

Lung Inflammation
Cases of lung inflammation have happened in some people who receive either STELARA or Ustekinumab and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare provider right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA or Ustekinumab.

Before you use or receive STELARA or Ustekinumab, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed above for serious infections or cancers.
• ever had an allergic reaction to any Ustekinumab product or any of its ingredients. Ask your healthcare provider if you are not sure.
• are allergic to latex. The needle cover on the prefilled syringe contains latex.
• have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with either STELARA or Ustekinumab should avoid receiving live vaccines. Tell your healthcare provider if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should avoid receiving the BCG vaccine during the 1 year before receiving either STELARA or Ustekinumab or 1 year after you stop receiving either STELARA or Ustekinumab.
• have any new or changing lesions within psoriasis areas or on normal skin.
• are receiving or have received allergy shots, especially for serious allergic reactions.
• receive or have received phototherapy for your psoriasis.
• are pregnant or plan to become pregnant. It is not known if either STELARA or Ustekinumab can harm your unborn baby. You and your healthcare provider should decide if you will receive STELARA or Ustekinumab.
• are breastfeeding or plan to breastfeed. STELARA and Ustekinumab can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive STELARA or Ustekinumab.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

When prescribed STELARA or Ustekinumab:

• Use STELARA and Ustekinumab exactly as your healthcare provider tells you to. The healthcare provider will determine the right dose of STELARA or Ustekinumab, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments.
• STELARA and Ustekinumab are intended for use under the guidance and supervision of your healthcare provider.
• In children, it is recommended that STELARA and Ustekinumab be administered by a healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of STELARA or Ustekinumab at home, you or a caregiver should receive training on the right way to prepare and inject STELARA or Ustekinumab.
• Do not try to inject STELARA or Ustekinumab until you have been shown how to inject STELARA or Ustekinumab by healthcare provider.

The most common side effects of STELARA and Ustekinumab include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, influenza, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with STELARA and Ustekinumab. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please read the full Prescribing Information and Medication Guide for STELARA and the full Prescribing Information and Medication Guide for Ustekinumab and discuss any questions you have with your doctor.

Please read the full Prescribing Information and Medication Guide for STELARA and the full Prescribing Information and Medication Guide for Ustekinumab and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

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Cautions Concerning Forward-Looking Statements
This statement contains “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 uncertainties materialize, 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 statement as a result of new information or future 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.