-- SIMPONI Recommended for Approval in Adult Patients with
Severe Active Non-Radiographic Axial Spondyloarthritis
LEIDEN, The Netherlands,
May 22, 2015 /PRNewswire/ -- Janssen
Biologics B.V. ("Janssen") announced today that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) adopted a positive opinion recommending approval for
the use of subcutaneous SIMPONI® (golimumab) for the
treatment of adults with severe active non-radiographic axial
spondyloarthritis (nr-AxSpA) with objective signs of inflammation
as indicated by elevated C-reactive protein (CRP) and/or magnetic
resonance imaging (MRI) evidence, who have had an inadequate
response to or are intolerant to nonsteroidal anti-inflammatory
drugs (NSAIDs).
Based on the CHMP's positive opinion, a final decision from the
European Commission is expected during the third quarter of 2015.
If approved, SIMPONI will become available for the treatment of
patients with severe active nr-AxSpA, a form of
spondyloarthritis—chronic inflammatory diseases affecting the
spine—in which the predominant symptom is back pain and stiffness.
It is estimated that 0.3 to 2.5 percent of the European population
are affected by some type of spondyloarthritis.1
"Today's CHMP positive opinion marks a milestone as we look to
make SIMPONI available to patients living with severe active
non-radiographic axial spondyloarthritis," said Newman Yeilding,
M.D., Vice President, Head of Immunology Development, Janssen
Research & Development, LLC. "We are committed to advancing
innovative therapeutics for patients with rheumatic diseases, and
we look forward to the European Commission's decision later this
year."
The CHMP adopted the opinion based on a review of data from the
Phase 3 GO-AHEAD trial, a MSD- (known as Merck in the United States and Canada) sponsored program conducted in
collaboration with Janssen, which evaluated the efficacy and safety
of SIMPONI compared with placebo in adults with severe active
nr-AxSpA. Patients had been diagnosed no more than five years prior
with chronic back pain of at least three months' duration and were
inadequately controlled with 30 days of optimal daily doses of at
least one NSAID or were intolerant to such therapy.
The study had two parts. In part one of the study, patients were
randomised equally to receive SIMPONI 50 mg or placebo at weeks 0,
4, 8 and 12. Beginning at week 16—part two of the study—all
patients began receiving open-label SIMPONI 50 mg every four weeks.
Part two was 44 weeks in duration, with 36 weeks of treatment and
an eight-week safety follow-up period. The primary endpoint of the
study was an Assessment in Ankylosing Spondylitis (ASAS) 20
response at week 16. Key secondary endpoints at week 16 included
ASAS 40 response, Bath Ankylosing Spondylitis Disease Activity
Index (BASDAI) 50 response, ASAS partial remission and change from
baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI Sacroiliac Joints
Scoring.
About Spondyloarthritis
Spondyloarthritis refers to a
family of chronic, inflammatory diseases that share common clinical
features, including inflammation of the joints and the entheses
(sites where ligaments and tendons attach to bones). AxSpA is a
type of spondyloarthritis that mainly affects the spine and pelvic
joints. The primary symptoms of AxSpA include pain and stiffness of
the spine. The disease can eventually progress to include bone
destruction, which can lead to spinal deformity and dysfunction.
Unlike ankylosing spondylitis, which is another type of AxSpA,
patients with nr-AxSpA may not present with traditional X-ray
evidence of structural damage in sacroiliac joins the
spine.2
About SIMPONI® (golimumab)
SIMPONI is a human
monoclonal antibody that targets and neutralises excess tumor
necrosis factor (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 in 85 countries for rheumatologic indications, including
the European Union (EU), where SIMPONI received European Commission
approval in October 2009 for the
treatment of moderate-to-severe, active rheumatoid arthritis in
combination with methotrexate, for the treatment of active and
progressive psoriatic arthritis alone or in combination with
methotrexate and for the treatment of severe, active ankylosing
spondylitis. In September 2013,
SIMPONI received European Commission approval for the treatment of
moderately to severely active ulcerative colitis. SIMPONI is
available either through the SmartJect®
autoinjector/prefilled pen or a prefilled syringe as a
subcutaneously administered injection.
Janssen Biotech, Inc. discovered and developed SIMPONI and
markets the product in the United
States. The Janssen Pharmaceutical Companies market 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 Merck &
Co., Inc.
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.
Important Safety Information (EU)
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, a physician with expertise in the
treatment of TB should be consulted. The benefit/risk balance
should be very carefully considered for the following: treatment of
latent TB infection must 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 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.
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.
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
pharmacological interactions. Patients should continue to be
monitored when switching from one biologic to another.
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 all times. Mild
injection site reactions commonly occur.
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 SIMPONI treatment.
The most common adverse drug reaction reported from clinical
trials through week 16 was upper respiratory tract infection (12.6
percent of SIMPONI-treated patients compared with 10.7 percent in
control-treated patients). In controlled Phase 3 trials through
Week 16 in RA, psoriatic arthritis and ankylosing spondylitis, 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.emea.europa.eu.
About Janssen Biologics B.V., Janssen Research &
Development, LLC and Janssen Biotech, Inc.
At Janssen, we
are dedicated to addressing and solving some of the most important
unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines and cardiovascular
and metabolic diseases. Driven by our commitment to patients, we
develop innovative products, services and healthcare solutions to
help people with 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 health care professionals
have access to the latest treatment information, support services
and quality care.
Janssen Biologics B.V., Janssen Research & Development, LLC
and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical
Companies of Johnson & Johnson. Please visit www.janssen.com
for more information.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development. 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 Biologics B.V., Janssen
Research & Development, LLC, Janssen Biotech, Inc. and/or
Johnson & Johnson. Risks and uncertainties include, but are not
limited to: challenges and uncertainties inherent in new product
development, including obtaining regulatory approvals; competition,
including technological advances, new products and patents attained
by competitors; challenges to patents; changes to applicable laws
and regulations, including global health care reforms; and trends
toward health care cost containment. A further list and description
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 28, 2014,
including in Exhibit 99 thereto, 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 or Johnson & Johnson undertakes to
update any forward-looking statement as a result of new information
or future events or developments.
References
1 Stolwijk C, Boonen A, van Tubergen A, Reveille JD.
Epidemiology of Spondyloarthritis. Rheum Dis Clin N Am.
2012;38(3):441-76. doi: 10.1016/j.rdc.2012.09.003.
2 Spondyloarthritis. The American College of
Rheumatology website.
https://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Spondylarthritis_%28Spondylarthropathy%29/.
Accessed October 23, 2014.
Media
Contact:
|
Investor
Contacts:
|
Brian
Kenney
|
Louise
Mehrotra
|
Office: +1
215-628-7010
|
Johnson &
Johnson
|
Mobile: +1
215-620-0111
|
Office: +1
732-524-6491
|
bkenney1@its.jnj.com
|
|
|
Lesley
Fishman
|
|
Johnson &
Johnson
|
|
Office: +1
732-524-3922
|
|
|