Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriat
Submissions demonstrate Janssen?s commitment to developing new options
for young patients
HORSHAM, PA, April 24, 2020 ? The Janssen Pharmaceutical Companies of
Johnson & Johnson today announced the submission of two supplemental Biologics
License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking
approval of SIMPONI ARIA? (golimumab) for the treatment of polyarticular juvenile
idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years
of age and older in combination with methotrexate. If approved for these indications,
SIMPONI ARIA would be the first anti-tumor necrosis factor (TNF)-alpha biologic
agent administered by intravenous infusion available for the treatment of these
juvenile arthritides.
Juvenile Idiopathic Arthritis (JIA) is a group of disorders characterized by arthritis
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persisting for at least six weeks before the age of 16 years.i
Approximately 300,000
children suffer from some form of JIA in the United States.ii The polyarticular form of
JIA is most common and is characterized by inflammation in more than four joints
and resembles adult rheumatoid arthritis (RA).iii Juvenile psoriatic arthritis (PsA) is
one of the rarest subtypes of JIA and is characterized by both joint inflammation and
skin lesions associated with psoriasis resembling adult PsA.iv,v
?All forms of JIA can be debilitating for children who live with the disease, and their
parents and physicians often have a difficult time establishing a treatment plan given
the limited options currently available for pediatric patients,? said Alyssa Johnsen,
M.D., Ph.D., Vice President and Rheumatology Disease Area Leader, Janssen
Research & Development, LLC. ?At Janssen, we are focused on addressing unmet
needs for all patients and are especially pleased to be taking these positive steps that
could make a new treatment option available for these young patients.?
The submissions are based on results from the GO-VIVA Phase 3 clinical trial, which
was an open-label study conducted to assess the pharmacokinetics, safety and
efficacy of SIMPONI ARIA in children with pJIA ages two to 17 years who had active
arthritis in five or more joints, despite receiving treatment with methotrexate for at
least two months. The trial also included patients with jPsA.
GO-VIVA was designed to extrapolate data from a pivotal Phase 3 clinical
development program for SIMPONI ARIA. Data extrapolation is the process of
estimating future trends or effects based on previous observations. With limited
pediatric patients available for clinical trial inclusion, researchers can extrapolate data
from adult patient trials to determine the potential efficacy and tolerability of a
treatment for the pediatric population.
About the GO-VIVA Clinical Trial
GO-VIVA is a Phase 3, open-label, single arm, multicenter study conducted across
nine countries with treatment received by 127 patients with active pJIA, despite
current treatment with methotrexate. GO-VIVA is included as a post-marketing
requirement under the Pediatric Research Equity Act (PREA) following the initial
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approval of SIMPONI ARIA for adults with moderately to severely active RA in 2013.
The purpose of the study was to evaluate the pharmacokinetics safety and efficacy of
SIMPONI ARIA in pJIA in pediatric patients aged two to 17 years. The
pharmacokinetic and efficacy data in pJIA patients were compared to adult RA
patients from the SIMPONI ARIA Phase 3 GO-FURTHER trial and the
pharmacokinetics and efficacy results in jPsA patients were compared to adult PsA
patients from the Phase 3 GO-VIBRANT trial.
About Juvenile Idiopathic Arthritis
JIA is a group of disorders characterized by arthritis persisting for at least six weeks
before the age of 16 years.i
Approximately 300,000 children in the U.S. suffer from
some form of JIA.ii
The polyarticular form of JIA causes inflammation in more than four joints and can be
rheumatoid factor-positive or negative, with rheumatoid factor-positive polyarticular
arthritis closely resembling adult RA.iii About 25 percent of children with JIA have the
polyarticular form.vi Polyarticular JIA poses challenges given the number of joints
involved in the condition and the refractory nature of the disease which can increase
the risk of joint damage.vi Weight-bearing joints and the jaw can be affected,
although the disease more commonly affects the small joints of the fingers and
hands.vii
Juvenile PsA is one of the rarest subtypes of JIA with an estimated 2 to 11 percent of
JIA patients affected by the disease.iv,v Juvenile patients experience many of the same
PsA symptoms as adults, including pain, stiffness and swelling in and around the
joints.iii
About SIMPONI ARIA? (golimumab) infusion
SIMPONI ARIA is the only fully human anti-TNF-alpha therapy administered via a 30-
minute infusion approved for the treatment of adults with moderately to severely
active RA, active PsA or active AS.
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SIMPONI ARIA? is a human anti-TNF-alpha monoclonal antibody that targets
both soluble and transmembrane bioactive forms of human TNF-alpha, a
protein that when overproduced in the body due to chronic inflammatory
diseases can cause inflammation. By binding with and blocking TNF-alpha,
SIMPONI ARIA? helps control inflammation. SIMPONI ARIA? is approved as a
30-minute infusion for the treatment of adult patients with moderately to
severely active RA used in combination with methotrexate, active PsA or active
AS. SIMPONI ARIA? is approved in 24 countries, including the U.S.
More information about SIMPONI ARIA? is available at www.SimponiARIA.com.
Janssen Biotech, Inc. discovered and developed SIMPONI ARIA?.
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
SIMPONI ARIA? (golimumab) is a prescription medicine. SIMPONI ARIA? 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
ARIA? and will closely 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 receive SIMPONI ARIA? 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
? warm, red, or painful skin or sores on your body
? diarrhea or stomach pain
? cough
? shortness of breath
? blood in phlegm
? weight loss
? burning when you urinate or urinate more than normal
? feel very tired
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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 ARIA? and during treatment with SIMPONI
ARIA?. Even if your TB testis negative, your doctor should carefully monitor you for
TB infections while you are taking SIMPONI ARIA?. People who had a negative TB skin
test before receiving SIMPONI ARIA? have developed active TB. Tell your doctor if you
have any of the following symptoms while taking or after taking SIMPONI ARIA?:
? 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
Tumor Necrosis Factor (TNF)-blocker medicines. For children and adults
receiving TNF blockers, including SIMPONI ARIA?, 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 a TNF blocker 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 ARIA? developed skin cancer. Tell your doctor if
any changes in the appearance of your skin or growths on your skin occur during or
after your treatment with SIMPONI ARIA?. Your doctor should periodically examine
your skin, especially if you have a history of skin cancer.
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
receiving SIMPONI ARIA? 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 receiving TNF-blocker medicines, such as SIMPONI ARIA?. Some of
these cases have been fatal. Your doctor should do blood tests before and after you
start treatment with SIMPONI ARIA?. 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
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? clay-colored bowel movements
? fever
? chills
? stomach discomfort
? skin rash
HEART FAILURE
Heart failure can occur or get worse in people who use TNF blockers, including
SIMPONI ARIA?. If you develop new or worsening heart failure with SIMPONI ARIA?,
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 ARIA?, can have nervous
system problems such as multiple sclerosis or Guillain-Barr? 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 or legs.
LIVER PROBLEMS
Serious liver problems can happen in people using TNF blockers, including SIMPONI
ARIA?. 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 people using TNF blockers, including SIMPONI
ARIA?. 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.
ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker medicines, including
SIMPONI ARIA?. Tell your doctor if you have any symptoms of an allergic reaction
while receiving SIMPONI ARIA? such as hives, swollen face, breathing trouble, or
chest pain. Some reactions can be serious and life-threatening.
OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you have psoriasis.
Tell your doctor if you are pregnant, planning to become pregnant, are breastfeeding,
or plan to breastfeed, or have a baby and received SIMPONI ARIA? during pregnancy.
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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.
COMMON SIDE EFFECTS
The most common side effects of SIMPONI ARIA? include: upper respiratory infection,
abnormal liver tests, decreased blood cells that fight infection, viral infections,
bronchitis, high blood pressure, and rash.
Please read the full Prescribing Information and Medication Guide for
SIMPONI ARIA? 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 Janssen, we're creating a future where disease is a thing of the past. We're the
Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that
future a reality for patients everywhere by fighting sickness with science, improving
access with ingenuity, and healing hopelessness with heart. We focus on areas of
medicine where we can make the biggest difference: Cardiovascular & Metabolism,
Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary
Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or
www.twitter.com/JanssenUS. Janssen Research & Development, LLC and Janssen
Biotech, Inc. are 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 SIMPONI ARIA. 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
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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 29, 2019, 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.
None of 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.
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i
Mayo Clinic. Juvenile idiopathic arthritis. Overview. Available at https://www.mayoclinic.org/diseasesconditions/juvenile-idiopathic-arthritis/symptoms-causes/syc-20374082. Accessed April 2, 2020.
ii National Institutes of Health. U.S. National Library of Medicine. Genetics Home Reference. Juvenile idiopathic
arthritis. Frequency. Available at https://ghr.nlm.nih.gov/condition/juvenile-idiopathic-arthritis#. Accessed April 2,
2020.
iii National Institutes of Health. U.S. National Library of Medicine. Genetics Home Reference. Juvenile idiopathic
arthritis. Description. Available at https://ghr.nlm.nih.gov/condition/juvenile-idiopathic-arthritis#. Accessed April 2,
2020.
iv Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007;369(9563):767-778.
v
Stoll ML, Punaro M. Psoriatic juvenile idiopathic arthritis: a tale of two subgroups. Curr Opin Rheumatol.
2011;23(5):437-443.
vi Oberle EJ, Harris JG, Verbsky JW. Polyarticular juvenile idiopathic arthritis - epidemiology and management
approaches. Clin Epidemiol. 2014;6:379?393. Published 2014 Oct 24. doi:10.2147/CLEP.S53168.
vii Creaky Joints. Juvenile Idiopathic Arthritis. Available at https://creakyjoints.org/education/juvenile-idiopathicarthritis/. Accessed April 2, 2020.