U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis

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HORSHAM, Pa. (October 7, 2025) - Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved SIMPONI® (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. This approval builds on the SIMPONI® indication for adults living with moderately to severely active UC, which together represents more than one million Americans living with this condition.¹

"Ulcerative colitis is a complex, lifelong condition that is often challenging to manage effectively, particularly for pediatric patients, where relatively few approved options are available," said Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. "The approval of SIMPONI represents a meaningful milestone, offering a therapy with well-established efficacy and safety along with subcutaneous dosing, for younger patients where treatment options have historically been limited."

The approval is supported by data from the PURSUIT program, which included two multi-center, open-label studies to evaluate the efficacy, safety, and pharmacokinetics of subcutaneously administered SIMPONI® for the treatment of pediatric UC. In the Phase 3 PURSUIT 2 study, the primary endpoint of clinical remission at Week 6 was achieved by 32% of patients. The secondary endpoints of clinical response at Week 6 was achieved by 58% and endoscopic improvement at Week 6 was achieved by 40% of patients receiving SIMPONI®.^a,b,c Among patients treated with SIMPONI® who were in clinical remission at Week 6, 57% maintained clinical remission of symptoms at Week 54. Safety results for this population are consistent with clinical trials of SIMPONI® in adults with UC.

SIMPONI® is administered as a pre-filled syringe and can be self-administered for patients aged 12 years and older after proper training by a healthcare provider. The recommended dosage for pediatric patients weighing at least 40 kg is 200 mg at Week 0, followed by 100 mg at Weeks 2, 6, and every 4 weeks thereafter; for pediatric patients weighing at least 15 kg to less than 40 kg, SIMPONI® is administered at 100 mg at Week 0, followed by 50 mg at Weeks 2, 6, and every 4 weeks thereafter.

This is the first pediatric approval for SIMPONI®, which is already approved for four indications, including adults living with moderate to severe rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS) and moderately to severely active UC. This approval is another important milestone for patients and is emblematic of Johnson & Johnson's continuous commitment to innovating to improve the lives of people living with chronic immune-mediated diseases.

Editor's Notes:
a. Clinical remission is defined as a Mayo score ≤2 points, with no individual subscore >1.
b. Clinical response is defined as a decrease from baseline in the Mayo score by >30% and >3 points, with either a decrease from baseline in the rectal bleeding subscore of >1 or a rectal bleeding subscore of 0 or 1.
c. Endoscopic remission is defined as an endoscopy subscore of 0 or 1 based on local endoscopy.

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.^1,2

ABOUT THE PHASE 3 PURSUIT 2 STUDY ( NCT03596645)
PURSUIT 2 is a Phase 3, multi-center open-label study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered SIMPONI^® for the treatment of moderately to severely active ulcerative colitis in pediatric patients two years of age and older.

ABOUT THE PHASE 1 PURSUIT PEDIATRIC PK STUDY ( NCT01900574)
PURSUIT Pediatric PK is a Phase 1 open-label study evaluating the safety and pharmacokinetics of subcutaneously administered SIMPONI^® for the treatment of moderately to severely active ulcerative colitis in pediatric patients two years of age and older. Participants in clinical response at Week 6 continued in the study extension with golimumab through Week 114.

ABOUT SIMPONI^® (golimumab)
Developed by Johnson & Johnson, SIMPONI^® is an anti-TNF biologic medicine that targets and blocks a protein called TNF-alpha (tumor necrosis factor-alpha).

SIMPONI^® is a prescription medicine approved in the U.S. to treat:

• adults with moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate (MTX)
• adults with active psoriatic arthritis (PsA), alone or with the medicine MTX
• adults with active ankylosing spondylitis (AS)
• adults and children weighing at least 33 pounds (15 kg) with moderately to severely active ulcerative colitis (UC)

SIMPONI^® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of the above condition(s).

Johnson & Johnson maintains exclusive worldwide marketing rights to SIMPONI^®. For more information, visit: https://www.simponi.com.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS
SIMPONI^® (golimumab) is a prescription medicine. SIMPONI^® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI^® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not start SIMPONI^® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV, or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

· fever, sweat, 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 than normal · feel very tired

Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SIMPONI^® and during treatment with SIMPONI^®. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking SIMPONI^®. People who had a negative TB skin test before receiving SIMPONI^® have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking SIMPONI^®:

· cough that does not go away · low grade fever

· weight loss · loss of body fat and muscle (wasting)

CANCER
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI^®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking other TNF blockers with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI^® have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI^®, tell your doctor.

USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including ORENCIA^® (abatacept), KINERET^® (anakinra), ACTEMRA^® (tocilizumab), RITUXAN^® (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI^® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).

HEPATITIS B INFECTION
If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use SIMPONI^®. Some of these cases have been fatal. Your doctor should do blood tests before and while you are using SIMPONI^®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

· feel very tired · dark urine · skin or eyes look yellow · little or no appetite · vomiting · muscle aches

· clay-colored bowel movements · fevers · chills · stomach discomfort · skin rash

HEART FAILURE
Heart failure, including new heart failure or worsening of heart failure that you already have, can occur or get worse in people who use TNF blockers, including SIMPONI^®. If you develop new or worsening heart failure with SIMPONI^®, you may need treatment in a hospital, and it may result in death. If you have heart failure before starting SIMPONI^®, your condition should be watched closely during treatment with SIMPONI^®. Call your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.

NERVOUS SYSTEM PROBLEMS
Rarely, people using TNF blockers, including SIMPONI^®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.

IMMUNE SYSTEM PROBLEMS
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, or swelling of the feet, ankles, and/or legs.

LIVER PROBLEMS
Serious liver problems can happen in people using TNF blockers, including SIMPONI^®. These problems can lead to liver failure and death. Call your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach (abdomen).

BLOOD PROBLEMS
Low blood counts have been seen with SIMPONI^®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising or bleeding easily, or looking pale.

ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI^®. Some reactions may be serious and can be life-threatening. Some of these reactions can happen after receiving your first dose of SIMPONI^®. Stop using SIMPONI^® and call your doctor right away if you have any symptoms of an allergic reaction such as hives, swollen face, breathing trouble, or chest pain.

OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you are allergic to rubber or latex. The needle cover on the prefilled syringe and SmartJect autoinjector contains dry natural rubber.

Tell your doctor if you are pregnant, planning to become pregnant, breastfeeding, plan to breastfeed, or have a baby and were using SIMPONI^® during pregnancy. Tell your baby's doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

The most common side effects of SIMPONI^® include: upper respiratory infection (runny nose, sore throat, and hoarseness or laryngitis), reaction at site of injection (redness, swelling, itching, pain, bruising, or tingling), and viral infections such as flu and oral cold sores.

PSORIASIS
New or worsening psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with SIMPONI^®.

These are not all of the possible side effects of SIMPONI^®. Tell your doctor about any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects.

Please read the full Prescribing Information and Medication Guide for SIMPONI^® 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 and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at https://www.innovativemedicine.jnj.com.

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 SIMPONI^®. 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 Rosen MJ, Dhawan A, Saeed SA. Inflammatory Bowel Disease in Children and Adolescents. JAMA Pediatr. 2015 Nov;169(11):1053-60. doi: 10.1001/jamapediatrics.2015.1982. PMID: 26414706; PMCID: PMC4702263.

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