Janssen Withdraws Application In European Union Seeking Approval Of
Intravenously Administered SIMPONI®
LEIDEN, Netherlands, May 19, 2014
LEIDEN, Netherlands, May 19, 2014 /PRNewswire/ -- Janssen Biologics B.V.
announced today that the company has withdrawn its application seeking a
change to the Marketing Authorization for SIMPONI® (golimumab) to add a new
pharmaceutical form of intravenous (I.V.) administration for the treatment of
adults with moderately to severely active rheumatoid arthritis (RA). Janssen
Biologics informed the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) of its decision following receipt of an
assessment report that indicated additional clinical data were required to
further evaluate the risk:benefit profile of the I.V. formulation.
"We have elected to withdraw our application seeking approval of SIMPONI I.V.
in the European Union as we are unable at this time to provide additional
clinical data beyond the pivotal Phase 3 results included in the current
submission," said Newman Yeilding, M.D., Head of Immunology Development,
Janssen Research & Development, LLC. "While we are disappointed that we will
be unable to pursue the approval of SIMPONI I.V. as a treatment for moderately
to severely active rheumatoid arthritis in the European Union, we are
confident that the Phase 3 data accumulated through the SIMPONI I.V. clinical
development program demonstrate a positive risk:benefit profile for this
anti-tumor necrosis factor (TNF)-alpha therapy."
The withdrawal of the SIMPONI I.V. application in the European Union (EU) has
no impact on SIMPONI subcutaneous or intravenous formulations in approved
indications worldwide and has no consequences on ongoing clinical trials.
About SIMPONI® ^ (golimumab) SIMPONI is a human monoclonal antibodythat
targets and neutralizes excess TNF-alpha, a protein that when overproduced in
the body due to chronic inflammatory diseases can cause inflammation and
damage to bones, cartilage and tissue.
SIMPONI is approved as a once-monthly subcutaneously administered treatment in
the EU for the treatment of moderately to severely active RA, active psoriatic
arthritis, active ankylosing spondylitis and moderately to severely active
ulcerative colitis (UC).SIMPONI is available in the EU as a subcutaneous
injection either through the SmartJect® prefilled pen or a prefilled syringe.
Janssen Biotech, Inc. discovered and developed SIMPONI and has marketing
rights to the product in the United States. The Janssen Pharmaceutical
Companies have marketing rights to SIMPONI ^ in Canada, Central and South
America, the Middle East, Africa and Asia Pacific.
In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution
rights to SIMPONI to Schering-Plough (Ireland) Company, a subsidiary of
In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution
rights to SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained
co-marketing rights in those countries.
For further information about SIMPONI outside of Europe, please consult the
relevant official product information applicable to that country location.
Important Safety Information (EU) – Subcutaneously Administered SIMPONI In
the European Union, SIMPONI is contraindicated in patients with active
tuberculosis, severe infections such as sepsis, opportunistic infections, in
patients with moderate or severe heart failure (NYHA Class III/IV), as well as
in patients who are hypersensitive to SIMPONI or any of its excipients.
Serious infections, including sepsis, pneumonia, tuberculosis (TB), invasive
fungal and other opportunistic infections have been observed with the use of
TNF antagonists including SIMPONI. Some of these infections have been fatal.
SIMPONI should not be given to patients with a clinically important, active
infection. Caution should be exercised when considering the use of SIMPONI in
patients with a chronic infection or a history of recurrent infection.
Patients must be monitored closely for infections including TB before, during
and after treatment with SIMPONI. If a patient develops a new serious
infection or sepsis, SIMPONI therapy should be discontinued and appropriate
antimicrobial therapy should be initiated until the infection is controlled.
Patients should be advised of, and avoid exposure to, potential risk factors
for infection as appropriate. For patients who have resided in or traveled to
regions where invasive fungal infections such as histoplasmosis,
coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of
SIMPONI treatment should be carefully considered before initiation of SIMPONI
therapy. All patients must be evaluated for the risk of TB, including latent
TB, prior to initiation of SIMPONI. If active TB is diagnosed, SIMPONI must
not be initiated. If latent TB is suspected or diagnosed then the benefit/risk
balance of SIMPONI treatment should be considered. Treatment of latent
tuberculosis infection should be initiated prior to therapy with SIMPONI.
Antituberculosis therapy prior to initiating SIMPONI should also be considered
in patients who have several or highly significant risk factors for
tuberculosis infection and have a negative test for latent tuberculosis.
Patients receiving SIMPONI should be monitored closely for signs and symptoms
of active tuberculosis during and after treatment, including patients who
tested negative for latent tuberculosis infections.
The use of TNF blocking agents including SIMPONI has been associated with
reactivation of hepatitis B virus (HBV) in patients who are chronic carriers
of the virus. Some of these cases have been fatal. Patients should be tested
for HBV infection before initiating treatment with SIMPONI. Carriers of HBV
who require treatment with SIMPONI should be closely monitored during
treatment with, and for several months following discontinuation of SIMPONI.
In patients who develop HBV reactivation, SIMPONI should be discontinued.
Lymphomas and leukemia have been observed in patients treated with TNF
blocking agents, including SIMPONI. The incidence of non-lymphoma malignancies
was similar to controls, and lymphoma is seen more often than in the general
population. The potential role of TNF-blocking therapy in the development of
malignancies is not known. Based on an exploratory clinical trial in patients
with COPD using another anti-TNF agent, caution should be exercised when using
any TNF-blocking therapy in COPD patients, as well as in patients with an
increased risk for malignancy due to heavy smoking. Rare post-marketing cases
of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients
treated with other TNF-blocking agents. This rare type of T-cell lymphoma has
a very aggressive disease course and is usually fatal.
Malignancies, some fatal, have been reported among children, adolescents and
young adults (up to 22 years of age) treated with TNF-blocking agents
(initiation of therapy ≤ 18 years of age) in the post marketing setting. A
risk for the development of malignancies in children and adolescents treated
with TNF-blockers cannot be excluded.
It is not known if SIMPONI treatment influences the risk for developing
dysplasia or colon cancer. All patients with ulcerative colitis who are at
increased risk for dysplasia or colon carcinoma, or who had a prior history of
dysplasia or colon carcinoma should be screened for dysplasia at regular
intervals before therapy and throughout their disease course.
Melanoma has been reported in patients treated with TNF-blocking agents,
including SIMPONI. Periodic skin examination is recommended, particularly for
patients with risk factors for skin cancer.
Worsening and new onset congestive heart failure (CHF) and increased mortality
due to CHF have been reported with another TNF blocker. SIMPONI has not been
studied in patients with CHF. SIMPONI should be used with caution in patients
with mild heart failure and must be discontinued if new or worsening symptoms
of heart failure appear.
TNF-blocking agents, including SIMPONI, have been associated in rare cases
with new onset or exacerbation of demyelinating disorders, including multiple
sclerosis. The benefits and risks of anti-TNF treatment should be carefully
considered before initiation of SIMPONI therapy in patients with pre-existing
or recent onset of demyelinating disorders.
There is limited safety experience of SIMPONI treatment in patients who have
undergone surgical procedures, including arthroplasty. A patient who requires
surgery while on SIMPONI should be closely monitored for infections, and
appropriate actions should be taken.
The possibility exists for TNF-blocking agents, including SIMPONI, to affect
host defenses against infections and malignancies. Treatment with SIMPONI may
result in the formation of auto-antibodies and, rarely, in the development of
a lupus-like syndrome.
There have been postmarketing reports of pancytopenia, leukopenia,
neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF
blockers. Cytopenias including pancytopenia, have been infrequently reported
with SIMPONI in clinical trials. Discontinuation of SIMPONI should be
considered in patients with significant hematologic abnormalities.
The concurrent administration of TNF-antagonists with anakinra or abatacept is
not recommended. Concurrent administration has been associated with increased
infections, including serious infections without increased clinical benefit.
The concomitant use of SIMPONI with other biological therapeutics used to
treat the same conditions as SIMPONI is not recommended because of the
possibility of an increased risk of infection, and other potential
Patients should continue to be monitored when switching from one biologic to
Patients treated with SIMPONI may receive concurrent vaccinations, except for
live vaccines. In postmarketing experience, serious systemic hypersensitivity
reactions have been reported following SIMPONI administration.
Allergic reactions may occur after first or subsequent administration of
SIMPONI. If an anaphylactic reaction or other serious allergic reactions
occur, administration of SIMPONI should be discontinued immediately and
appropriate therapy initiated.
The needle cover on the syringe in the pre-filled pen is manufactured from dry
natural rubber containing latex, and may cause allergic reactions in
individuals sensitive to latex. SIMPONI also contains sorbitol; patients with
rare hereditary problems of fructose intolerance should not take SIMPONI.
Patients should be given detailed instructions on how to administer SIMPONI.
After proper training, patients may self inject if their physician determines
that this is appropriate. The full amount of SIMPONI should be administered at
Women of childbearing potential must use adequate contraception to prevent
pregnancy and continue its use for at least 6 months after the last SIMPONI
treatment. Women must not breast feed during and for at least 6 months after
The most common adverse drug reaction reported in the controlled portion from
clinical trials was upper respiratory tract infection (12.6 percent of
SIMPONI-treated patients compared with 10.7 percent in control-treated
patients). In the controlled periods of pivotal trials, 5.1 percent of
SIMPONI-treated patients had injection site reactions compared with 2.0
percent in control-treated patients. The majority of the injection site
reactions were mild and moderate, and the most frequent manifestation was
injection site erythema.
The SIMPONI Patient Alert Card provides safety information to the patient. It
should be given and explained to all patients before treatment. Patients must
show the Alert Card to any doctor involved in his/her treatment, during and up
to 6 months after SIMPONI treatment.
For complete EU prescribing information, please visit www.ema.europa.eu .
About Janssen At Janssen, we are dedicated to addressing and solving some of
the most important unmet medical needs of our time in oncology, immunology,
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serious diseases throughout the world. Beyond its innovative medicines,
Janssen is at the forefront of developing education and public policy
initiatives to ensure patients and their families, caregivers, advocates and
healthcare professionals have access to the latest treatment information,
support services and quality care.
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