HORSHAM, Pa. (October 31, 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 ulcerative colitis (UC). Ulcerative colitis affects approximately one million people in the U.S., with an increasing rate in the pediatric population, who often experience more severe symptoms than adults.1,2
This submission is supported by data from the Phase 3 UNIFI Jr clinical trial, a multicenter interventional study to evaluate the efficacy, safety, and pharmacokinetics of STELARA® for the treatment of pediatric UC through Week 52.
“Although there have been significant scientific advances in the treatment of inflammatory bowel diseases, many children with ulcerative colitis still face considerable challenges in managing their condition and limited approved treatment options,” said Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “The FDA filing of STELARA in the pediatric population, backed by clinical data and its long-established efficacy and safety profile in existing indications, represents a crucial step toward expanding treatment options and addressing unmet needs in this younger population with relatively few treatments available.”
STELARA® is currently approved for the treatment of adults with moderately to severely active Crohn’s disease and UC, in addition to adults and children six years and older with active psoriatic arthritis and moderate to severe plaque psoriasis. In June 2025, Johnson & Johnson submitted an sBLA to the FDA seeking approval of STELARA® for the treatment of children two years and older with moderately to severely active Crohn’s disease. These pediatric submissions reflect Johnson & Johnson’s ongoing commitment to advancing innovative therapies for people with immune-mediated diseases across age groups.
Editor’s Notes:
a. STELARA® is not currently approved in the U.S. to treat moderately to severely active pediatric ulcerative colitis or Crohn’s disease
ABOUT PEDIATRIC ULCERATIVE COLITIS
Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) in which chronic inflammation of the colon occurs. In UC, the immune system inappropriately attacks and damages healthy cells in the lining of the colon. Patients can experience a range of unpredictable symptoms, which may include loose and more frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue. More than one million people in the U.S. are living with UC, making it one of the largest populations globally affected by this disease, approximately 20 percent of individuals are pediatric.1
ABOUT THE PHASE 3 UNIFI JR STUDY (
NCT04630028)
UNIFI Jr is a Phase 3 multicenter study of the efficacy, safety and pharmacokinetics of ustekinumab as open-label intravenous induction treatment followed by randomized double-blind subcutaneous ustekinumab maintenance in pediatric participants with moderately to severely active ulcerative colitis. Participants in clinical response at Week 8 with ustekinumab were assessed through Week 52.
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.
- 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® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects, including:
Serious Infections
STELARA® may lower your ability to fight infections and may increase your risk of infections. Some people have serious infections during treatment with STELARA®, 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® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
· If your healthcare provider feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.
You should not start STELARA® if you have any kind of infection unless your healthcare provider says it is okay.
Before starting STELARA®, tell your healthcare provider if you:
· think you have an infection or have symptoms of an infection such as:
| o fever, sweats, or chills o muscle aches o cough o shortness of breath o blood in phlegm | o weight loss o warm, red, or painful skin or sores on your body o diarrhea or stomach pain o burning when you urinate or urinate more often than normal o 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®, 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® 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® may also be more likely to get these infections.
Cancers
STELARA® 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 STELARA®. Tell your healthcare provider if you have any new skin growths.
Serious Allergic Reactions
Serious allergic reactions can occur. Stop using STELARA® 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 tightness, 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 STELARA® 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®.
Before you use or receive STELARA®, 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 STELARA® 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 STELARA® 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 one year before receiving STELARA® or one year after you stop receiving STELARA®.
· 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 STELARA® can harm your unborn baby. You and your healthcare provider should decide if you will receive STELARA®.
· are breastfeeding or plan to breastfeed. STELARA® can pass into your breast milk.
· talk to your healthcare provider about the best way to feed your baby if you receive STELARA®.
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®:
· Use STELARA® exactly as your healthcare provider tells you to. The healthcare provider will determine the right dose of STELARA®, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments.
· STELARA® is intended for use under the guidance and supervision of your healthcare provider. In children, it is recommended that STELARA® be administered by a healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of STELARA® at home, you or a caregiver should receive training on the right way to prepare and inject STELARA®. Do not try to inject STELARA® until you have been shown how to inject STELARA® by a healthcare provider.
Common side effects of STELARA® 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®. 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 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.
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.
Follow us at @JNJInnovMed.
Janssen Biotech, Inc. is a Johnson & Johnson company.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding STELARA®. 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 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:
1 Crohn’s & Colitis Foundation of America. The Facts About Inflammatory Bowel Diseases. Accessed September 2025. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
2 Prevalence of Pediatric Inflammatory Bowel Disease in the United States: Pooled Estimates From Three Administrative Claims Data Sources. Kappelman, Michael D.Brensinger, Colleen Parlett, Lauren E.Hurtado-Lorenzo, AndresLewis, James D. et al. Gastroenterology, Volume 168, Issue 5, 980 - 982.e2
Media contact:
Britt Harmon
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bharmon1@its.jnj.com
Investor contact:
Lauren Johnson
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