KENILWORTH, New Jersey,
May 26, 2015 /PRNewswire/ --
MSD, known as Merck & Co., Inc. in the United States and Canada,- today announced that
SIMPONI®(golimumab) has received CHMP positive
opinion for the treatment of adult patients with severe, active
non-radiographic axial spondyloarthritis (nr-axial SpA) 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).[1] Once the EU
commission issues their EC decision, and if approved, nr-axial SpA
patients can be considered for the once-monthly subcutaneous
injection with SIMPONI® (golimumab).
(Logo:
http://photos.prnewswire.com/prnh/20141215/720768 )
The CHMP positive opinion was based on the findings from the
GO-AHEAD study, which demonstrated significant clinical improvement
in patients with active nr-axial SpA treated with golimumab,
compared with patients treated with placebo, over 16
weeks.[2]
"The indication of SIMPONI® in
non-radiographic axial spondyloarthritis will add to a number of
existing indications in rheumatology and gastroenterology,"
explains Dr Sean Curtis, VP,
Immunology Clinical Research at MSD. "Physicians will have an
option to help address the treatment needs of a significant group
of their patients."
The term Axial Spondyloarthritis (axial SpA), which encompasses
both nr-axial SpA and ankylosing spondylitis
(AS),[3] is a painful and
potentially progressive condition that mainly affects the spine and
pelvic joints, commonly characterised by chronic lower back pain
and stiffness.[4] The burden of
disease in nr-axial SpA is similar to
AS.[5]
Once approved, SIMPONI® will become available as a
treatment option for patients with severe active nr-axial SpA. This
will add to the existing approved indications in rheumatology: AS,
psoriatic arthritis (PsA) and rheumatoid arthritis (RA).
SIMPONI® is also approved for the treatment of
ulcerative colitis.[6]
Notes to Editors:
About GO-AHEAD
GO-AHEAD was a Phase 3b double-blind, randomized,
placebo-controlled trialconducted in patients 18 to 45 years of age
with active nr-axial SpA, diagnosed according to the ASessment in
Ankylosing Spondylitis (ASAS)
criteria.[2]
The study evaluated 197 patients who were treated with either
golimumab 50 mg (n=97) or placebo (n=100) subcutaneous injections
every four weeks. The mean patient age was 31 years and more than
half of the patients were male (57 percent). The primary endpoint
of the study was the percentage of patients who attained ASAS20 at
week 16. Key secondary endpoints included percentage of patients
attaining ASAS40, ASAS partial remission, and Bath AS Disease
Activity Index (BASDAI) 50; and change from baseline in sacroiliac
joint inflammation on MRI (SPondyloArthritis Research Consortium of
Canada [SPARCC]
score).[2]
The study also assessed a subgroup of patients who showed
objective signs of inflammation (OSI) by MRI or elevated C-reactive
protein (CRP) at baseline. This subset of patients comprised
approximately 80 per cent of the total
population.[2]
About Axial Spondyloarthritis
Axial spondyloarthritis is a painful and potentially progressive
form of inflammatory arthritis that mainly affects the spine and
pelvic joints, and most commonly results in chronic lower back
pain.[4] It typically begins in
the late teens and early twenties and in severe cases can result in
complete fusion of the spinal vertebrae and cause structural damage
to hips and other joints.[4] The
term axial spondyloarthritis covers both non-radiographic axial
spondyloarthritis and ankylosing
spondylitis.[3] In patients with
nr-axial SpA, patients experience symptoms but damage to the joints
does not fulfill the modified New York Criteria for AS on
X-ray.[7] The burden of disease in
nr-axial SpA is similar to AS.[4]
A proportion of these nr-axial SpA patients may progress to
ankylosing spondylitis with typical radiographic
changes.[8] Often misdiagnosed as
"just back pain" in the early
stages,[5] axial spondyloarthritis
is a systemic inflammatory disease that, in addition to its effect
on the spine, can affect other areas such as peripheral joints,
eyes, and the bowel.[4]
About SIMPONI®(golimumab)
SIMPONI® is a human monoclonal antibody that targets
and neutralises tumour 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.
Licensed indications for golimumab include: moderate to
severe, active RA in adults, in combination with methotrexate, when
the response to disease-modifying anti-rheumatic drug (DMARD)
therapy including methotrexate has been inadequate; severe, active
and progressive RA, in combination with methotrexate, in adults not
previously treated with methotrexate; active and progressive PsA in
adult patients, alone or in combination with methotrexate, when the
response to previous DMARD therapy has been inadequate; and severe,
active ankylosing spondylitis in adults who have responded
inadequately to conventional therapy. Once approved,
SIMPONI®will be indicated for the treatment of
adults with severe, active nr-axial SpA 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).
Golimumab is also the first and only subcutaneous anti-tumor
necrosis factor (TNF)-alpha treatment administered as an
every-four-week maintenance therapy for the treatment of adult
patients with moderately to severely active ulcerative colitis who
have had an inadequate response to conventional therapy, including
corticosteroids and 6-mercaptopurine or azathioprine, or who are
intolerant to or have medical contraindications for such therapies.
Golimumab is available either through the
SmartJect® autoinjector/prefilled pen or a
prefilled syringe as a SC administered
injection.[6]
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 Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses
distribution rights to SIMPONI® to Mitsubishi
Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses
distribution rights for SIMPONI® to
Schering-Plough (Ireland) Company,
a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.
Please refer to the Summary of Product Characteristics for full
information on 'SIMPONI®' including
contraindications, precautions, special warnings and side effects.
Available from:
http://www.medicines.org.uk/emc/medicine/23766
Important Safety Information
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, 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
should be monitored for signs and symptoms of infection before,
during and for several months after treatment with SIMPONI. If a
patient develops a new serious infection or sepsis, SIMPONI therapy
should be discontinued and appropriate antimicrobial or antifungal
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. Patients must be evaluated for the risk of
tuberculosis (TB), including latent tuberculosis, 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 significant risk
factors for tuberculosis infection and have a negative test for
latent tuberculosis, or for patients with a past history of latent
or active TB in whom an adequate course of treatment cannot be
confirmed. 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 in patients who
are chronic carriers of the virus. Some of these cases have
been fatal. Chronic carriers of hepatitis B should be appropriately
evaluated and monitored prior to the initiation of, 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, 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.
Patients treated with SIMPONI may receive concurrent
vaccinations, except for live vaccines. Non-serious allergic
reactions associated with SIMPONI occurred in clinical trials, and
included urticaria, bronchospasm, and hypersensitivity. In
post-marketing experience, serious systemic hypersensitivity
reactions (including anaphylactic reaction) have been reported
following SIMPONI administration. Some of these reactions occurred
after the first 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. All patients
should be monitored for anaphylactic or other serious allergic
reactions.
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. In case of severe
reaction(s) SIMPONI should be discontinued.
Women of childbearing potential must use adequate contraception
to prevent pregnancy and continue its use for at least six months
after the last SIMPONI treatment. Women must not breastfeed during
and for at least six months after SIMPONI treatment.
The most common adverse reaction reported from the controlled
period of pivotal 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 period
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 six months after
SIMPONI treatment.
For complete EU prescribing information, please visit
http://www.ema.europa.eu.
About MSD
Today's MSD, known as Merck (NYSE: MRK) in the United States and Canada, is a global healthcare leader working
to help the world be well. Through our prescription medicines,
vaccines, biologic therapies and animal health products, we work
with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to healthcare through far-reaching policies,
programs and partnerships. For more information, visit
http://www.msd.com and connect with us on Twitter, Facebook and
YouTube.
MSD/Merck Forward-Looking Statement
This news release includes "forward-looking statements" within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck's
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States
and internationally; global trends toward health care cost
containment; technological advances, new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; Merck's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of Merck patents and other protections for innovative
products; and the exposure to litigation, including patent
litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Merck's 2014 Annual
Report on Form 10-K and the company's other filings with the
Securities and Exchange Commission (SEC) available at the SEC's
Internet site (http://www.sec.gov).
References
- Committee for Medicinal Products for Human Use. Summary of
opinion (post authorisation): Simponi. Available at:
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500187055.
Accessed May 2015.
- J.Sieper et al. A Randomized, Double-Blind,
Placebo-Controlled, 16-Week Study of Subcutaneous Golimumab in
Patients with Active Nonradiographic Axial Spondyloarthritis.
Abstract 2938. American College of Rheumatology, Boston, 15-19 November,
2014
http://acrabstracts.org/abstracts/a-randomized-double-blind-placebo-controlled-16-week-study-of-subcutaneous-golimumab-in-patients-with-active-nonradiographic-axial-spondyloarthritis/
Accessed May 2015.
- National Anklyosing Spondylitis society website. Available at:
http://nass.co.uk/. Accessed May
2015.
- American College of Rheumatology (ACR). Spondylarthritis
(Spondylarthropathy) website. Available at:
https://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Spondylarthritis_(Spondylarthropathy)/.
Accessed April 2015.
- Kiltz U et al. Do patients with non-radiographic axial
spondyloarthritis differ from patients with ankylosing spondylitis?
Arthritis Care Res. 2012 Sep;64(9):1415-1422.
- SIMPONI. Summary of product characteristics. Available at:
http://www.medicines.org.uk/emc/medicine/23766. Accessed
May 2015.
- Colbert RA. Early axial spondyloarthritis Curr Opin
Rheumatol. 2010 Sep; 22(5): 603-607.
- Poddubnyy D et al. Rates and predictors of radiographic
sacroiliitis progression over 2 years in patients with axial
spondyloarthritis. Ann Rheum Dis. 2011;70(8):1369-1374.
For further information please
contact:
Harry Brady (MSD)
+44(0)7974-444-851
harry.brady@merck.com
Rebecca Aris (Pegasus)
+44(0)1273-712034
raris@thisispegasus.co.uk