HORHSAM, Pa. (December 16, 2024) – Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of SIMPONI® (golimumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC). SIMPONI is currently approved for the treatment of adults living with moderately to severely active UC.
The sBLA is supported by data from the PURSUIT program, which include multi-center, open-label studies evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered SIMPONI® for the treatment of pediatric UC.
“This submission marks an important step in addressing the unique and pressing high unmet needs of children and adolescents living with ulcerative colitis, a challenging and lifelong inflammatory disease,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “At Johnson & Johnson, we are committed to designing clinical programs that prioritize underrepresented populations, including pediatric patients living with immune-mediated diseases, to ensure access to safe and effective treatment options. We look forward to working with the Agency in their review of this SIMPONI® pediatric application.”
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, and approximately 20 percent of those individuals are children. Ulcerative colitis can be a challenging disease to treat especially in younger populations, reinforcing the need for additional treatment options.
Editor’s Notes:
a. SIMPONI® is not currently approved to treat moderately to severely active pediatric ulcerative colitis (UC)
ABOUT PEDIATRIC ULCERATIVE COLITIS
Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. It is the result of the immune system’s overactive response. 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 those individuals are pediatric.
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.
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 with moderately to severely active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated, or if it is necessary to continue taking steroid medicines.
SIMPONI® is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults living with the above condition(s).
Johnson & Johnson maintains exclusive worldwide marketing rights to SIMPONI®. For more information, visit: 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 · weight loss | · low grade fever · 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
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with 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 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. Your doctor will closely monitor you if you have heart failure. Tell 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, swelling of the feet, ankles, and/or legs.
LIVER PROBLEMS
Serious liver problems can happen in people using TNF blockers, including SIMPONI®. Contact 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.
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, bleeding easily, or paleness.
OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber. Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding 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.
ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI®. Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.
Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections.
PSORIASIS
New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.
Please read the full Prescribing Information, including Medication Guide, for SIMPONI® and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 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 Research & Development, LLC, Janssen Biotech, Inc. and Janssen Scientific Affairs, LLC are Johnson & Johnson companies.
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 Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen Scientific Affairs, LLC and/or 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen Scientific Affairs, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new informati
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