Janssen Submits Application To U.S. FDA Seeking Approval Of STELARA® (ustekinumab) For Treatment Of Moderately To Severely Active Ulcerative Colitis

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Janssen Pharmaceutical Companies of Johnson & Johnson

Dec 20, 2018, 16:30 ET

HORSHAM, Pa., Dec. 20, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of STELARA^® (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis. STELARA is the first and only biologic targeting interleukin (IL)-12 and IL-23 cytokines, which evidence suggests play an important role in inflammation associated with auto-immune conditions, such as ulcerative colitis. STELARA is approved in many countries, including the U.S., for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis and moderate to severe Crohn's disease.

"We're excited to bring this innovative therapy, with a proven track record in Crohn's and other immune diseases, one step closer to being available for people living with ulcerative colitis," said Scott E. Plevy, M.D., Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC. "This submission builds upon our 20-year legacy of research and development to address unmet needs of people living with inflammatory bowel diseases."

The submission is based on data from the Phase 3 UNIFI global clinical development program, which included two studies (one induction and one maintenance study) evaluating the efficacy and safety of STELARA for the treatment of moderately to severely active ulcerative colitis in adults. Data from the Phase 3 induction study were recently presented at the 2018 American College of Gastroenterology and United European Gastroenterology Week annual meetings, and results from the Phase 3 maintenance study will be presented at future scientific meetings next year.

"We hear from so many people with ulcerative colitis that there is a significant need for additional therapeutic options. STELARA will offer a new mechanism of action that blocks IL-12 and IL-23 proteins and thereby inflammation of the colon," said Andrew Greenspan, M.D., Vice President, Immunology Medical Affairs, Janssen Scientific Affairs, LLC.

About Ulcerative Colitis

More than five million people worldwide are living with Crohn's disease and ulcerative colitis—commonly known as IBD. Ulcerative colitis, or UC, affects nearly 907,000 people in the United States, with approximately 38,000 new cases diagnosed each year.¹ UC is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucous. It is the result of an abnormal response by your body's immune system. Symptoms vary but may include loose and more urgent bowel movements, persistent diarrhea, abdominal pain, bloody stool, loss of appetite, weight loss and fatigue.²

About STELARA^®(ustekinumab)

STELARA^®(ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn's disease who have failed or were intolerant to immunomodulators or corticosteroids; or failed or were intolerant to anti-TNF therapies.

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. While taking STELARA^®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

Your doctor should check you for TB before starting STELARA^® and watch you closely for signs and symptoms of TB during treatment with STELARA^®.
If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA^®.

You should not start taking STELARA^® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA^®, tell your doctor 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
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 doctor right away if you have any symptoms of an infection (see above). 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 doctor 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 doctor if you have any new skin growths.

Reversible posterior leukoencephalopathy syndrome (RPLS)

RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions

Serious allergic reactions can occur. Stop using STELARA^® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

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 doctor right away if you develop shortness of breath or a cough that doesn't go away during treatment with STELARA^®.

Before receiving STELARA^®, tell your doctor about all of your medical conditions, including if you:

have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS.
ever had an allergic reaction to STELARA^® or any of its ingredients. Ask your doctor 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 take STELARA^® should not receive live vaccines. Tell your doctor 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 not receive 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 doctor should decide if you will receive STELARA^®.
are breastfeeding or plan to breastfeed. It is thought that STELARA^®passes into your breast milk. Talk to your doctor about the best way to feed your baby if you receive STELARA^®.

Tell your doctor 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 doctor and pharmacist when you get a new medicine.

When prescribed STELARA^®:

Use STELARA^® exactly as your doctor tells you to. STELARA^® is intended for use under the guidance and supervision of your doctor.
STELARA^® is intended for use under the guidance and supervision of your doctor. In children 12 years and older, it is recommended that STELARA^® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA^® at home, you should receive training on the right way to prepare and inject STELARA^®. Your doctor will determine the right dose of STELARA^® for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA^® yourself until you or your caregiver have been shown how to inject STELARA^® by your doctor or nurse.

Common side effects of STELARA^® include: upper respiratory infections, headache, and tiredness in psoriasis patients; joint pain and nausea in psoriatic arthritis patients; and upper respiratory infections, redness at the injection site, vaginal yeast infections, itching, urinary tract infections, and vomiting in Crohn's disease patients. 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, including the 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 www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http://www.janssen.com/. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding new study data on 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 Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies 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, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent 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. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.