THOUSAND OAKS, Calif.,
Nov. 4, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that the U.S. Food and Drug
Administration (FDA) has approved the supplemental Biologics
License Application (sBLA) for the expanded use of
ENBREL® (etanercept), making it the first and only
systemic therapy to treat pediatric patients (ages 4-17) with
chronic moderate-to-severe plaque psoriasis.
"As many parents of children with moderate-to-severe plaque
psoriasis can tell you, there is a need for FDA approved systemic
therapies in the pediatric setting. Until now, no biologics —
which are effective in treating adults with moderate-to-severe
plaque psoriasis — had been approved in the U.S. for the treatment
of moderate-to-severe plaque psoriasis in children," said
Randy Beranek, president and chief
executive officer of the National Psoriasis Foundation. "This new
approval is an important development for this patient community, as
well as their parents and families, and marks a significant
milestone in advancing the treatment of children living with this
devastating disease."
The approval is based on results from a Phase 3 one-year study
and its five-year open-label extension study to evaluate the safety
and efficacy of ENBREL in pediatric patients, ages 4 to 17, with
chronic moderate-to-severe plaque psoriasis. In addition to
demonstrating significant efficacy, the adverse events were similar
to those seen in previous studies in adults with moderate-to-severe
plaque psoriasis.
"The need for an effective treatment for chronic
moderate-to-severe pediatric psoriasis patients is high, and safety
is always a concern when it comes to treating children. ENBREL has
over a decade of experience in adult moderate to severe plaque
psoriasis, and that proven track record matters to healthcare
professionals, as well as the parents of children with
moderate-to-severe plaque psoriasis," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "Today's FDA approval shows
that innovation doesn't stop with a drug's first market approval,
and further reflects Amgen's commitment to continually unlock and
expand the therapeutic potential of our medicines in the hopes of
filling unmet patient needs."
Learn more about this expanded use of ENBREL
at www.enbrel.com or by calling 1-888-4ENBREL.
About Psoriasis
Psoriasis is a serious, chronic
inflammatory disease that causes raised, red, scaly patches to
appear on the skin, typically affecting the outside of the elbows,
knees or scalp, though it can appear on any
location.1,2 Approximately 125 million people
worldwide have psoriasis and 80 percent of those patients have
plaque psoriasis.3,4 About one-third of psoriasis
cases are pediatric.5
About
ENBREL® (etanercept)
ENBREL is
a soluble form of a tumor necrosis factor (TNF) receptor with a
clinical efficacy and safety profile established over 15 years of
collective clinical experience. ENBREL was first approved in 1998
for moderate-to-severe rheumatoid arthritis. ENBREL was approved in
1999 to treat moderate-to-severe polyarticular juvenile idiopathic
arthritis, in 2002 to treat psoriatic arthritis, in 2003 for the
treatment of patients with ankylosing spondylitis, and in 2004 to
treat moderate-to-severe plaque psoriasis in adults. Prescription
ENBREL is given by injection.
ENBREL indications in the U.S.:
- ENBREL is indicated for reducing signs and symptoms, inducing
major clinical response, inhibiting the progression of structural
damage, and improving physical function in patients with
moderately-to-severely active rheumatoid arthritis (RA). ENBREL can
be initiated in combination with methotrexate (MTX) or used
alone.
- ENBREL is indicated for reducing signs and symptoms of
moderately-to-severely active polyarticular juvenile idiopathic
arthritis in patients ages two and older.
- ENBREL is indicated for reducing signs and symptoms, inhibiting
the progression of structural damage of active arthritis, and
improving physical function in patients with psoriatic arthritis.
ENBREL can be used with or without methotrexate.
- ENBREL is indicated for reducing signs and symptoms in patients
with active ankylosing spondylitis.
- ENBREL is indicated for the treatment of patients 4 years or
older with chronic moderate-to-severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.
ENBREL U.S. Important Safety Information
Patients treated with ENBREL are at increased risk for
developing serious infections that may lead to hospitalization or
death. Most patients who developed these infections were taking
concomitant immunosuppressants such as methotrexate or
corticosteroids or were predisposed to infection because of their
underlying disease. ENBREL should not be initiated in the presence
of sepsis, active infections, or allergy to ENBREL or its
components. ENBREL should be discontinued if a patient develops a
serious infection or sepsis. Reported infections include: 1) Active
tuberculosis (TB), including reactivation of latent TB. Patients
with TB have frequently presented with disseminated or
extrapulmonary disease. Patients should be tested for latent TB
before ENBREL use and periodically during therapy. Treatment for
latent infection should be initiated prior to ENBREL use, 2)
Invasive fungal infections, including histoplasmosis,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients with histoplasmosis or other invasive
fungal infections may present with disseminated, rather than
localized, disease. Antigen and antibody testing for histoplasmosis
may be negative in some patients with active infection. Empiric
antifungal therapy should be considered in patients at risk for
invasive fungal infections who develop severe systemic illness, and
3) Bacterial, viral, and other infections due to opportunistic
pathogens, including Legionella and Listeria.
The risks and benefits of treatment with ENBREL should be
carefully considered prior to initiating therapy in patients 1)
with chronic or recurrent infection, 2) who have been exposed to
TB, 3) who have resided or traveled in areas of endemic TB or
endemic mycoses, or 4) with underlying conditions that may
predispose them to infections such as advanced or poorly controlled
diabetes. Patients should be closely monitored for the development
of signs and symptoms of infection during and after treatment with
ENBREL, including the possible development of TB in patients who
tested negative for latent TB prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been
reported in children and adolescent patients treated with tumor
necrosis factor (TNF) blockers, including ENBREL.
In adult clinical trials of all TNF blockers, more cases of
lymphoma were seen compared to control patients. The risk of
lymphoma may be up to several-fold higher in RA patients. The role
of TNF blocker therapy in the development of malignancies is
unknown. Cases of acute and chronic leukemia have been reported in
association with postmarketing TNF blocker use in RA and other
indications. The risk of leukemia may be higher in patients with RA
(approximately 2-fold) than the general population. Melanoma and
non-melanoma skin cancer (NMSC) have been reported in patients
treated with TNF blockers, including ENBREL. Periodic skin
examinations should be considered for all patients at increased
risk for skin cancer. In patients who initiated therapy at ≤ 18
years of age, approximately half of the reported malignancies were
lymphomas (Hodgkin's and non-Hodgkin's lymphoma). Other cases
included rare malignancies usually associated with
immunosuppression and malignancies that are not usually observed in
children and adolescents. Most of the patients were receiving
concomitant immunosuppressants.
Treatment with TNF-blocking agents, including ENBREL, has been
associated with rare (< 0.1%) cases of new onset or exacerbation
of central nervous system demyelinating disorders, some presenting
with mental status changes and some associated with permanent
disability, and with peripheral nervous system demyelinating
disorders. Cases of transverse myelitis, optic neuritis, multiple
sclerosis, Guillain-Barré syndromes, other peripheral demyelinating
neuropathies, and new onset or exacerbation of seizure disorders
have been reported in postmarketing experience with ENBREL therapy.
Prescribers should exercise caution in considering the use of
ENBREL in patients with preexisting or recent-onset central or
peripheral nervous system demyelinating disorders.
Cases of worsening congestive heart failure (CHF) and, rarely,
new-onset cases have been reported in patients taking ENBREL.
Caution should be used when using ENBREL in patients with CHF.
These patients should be carefully monitored. Rare cases of
pancytopenia, including aplastic anemia, some fatal, have been
reported. The causal relationship to ENBREL therapy remains
unclear. Exercise caution when considering ENBREL in patients who
have a previous history of significant hematologic abnormalities.
Advise patients to seek immediate medical attention if they develop
signs or symptoms of blood dyscrasias or infection. Consider
discontinuing ENBREL if significant hematologic abnormalities are
confirmed. Reactivation of hepatitis B has been reported in
patients who were previously infected with hepatitis B virus (HBV)
and received concomitant TNF-blocking agents, including ENBREL.
Most reports occurred in patients also taking immunosuppressive
agents, which may contribute to hepatitis B reactivation. Exercise
caution when considering ENBREL in these patients.
Allergic reactions associated with administration of ENBREL
during clinical trials have been reported in < 2% of patients.
If an anaphylactic reaction or other serious allergic reaction
occurs, administration of ENBREL should be discontinued immediately
and appropriate therapy initiated. Live vaccines should not be
administered to patients on ENBREL. Pediatric patients, if
possible, should be brought up to date with all immunizations prior
to initiating ENBREL. In patients with exposure to varicella virus,
temporarily discontinue ENBREL and consider prophylactic treatment
with Varicella Zoster Immune Globulin. Autoantibodies may develop
with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis
may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL
if lupus-like syndrome or autoimmune hepatitis develops. The use of
ENBREL in patients with Wegener's granulomatosis receiving
immunosuppressive agents (e.g., cyclophosphamide) is not
recommended. Based on a study of patients treated for alcoholic
hepatitis, exercise caution when using ENBREL in patients with
moderate-to-severe alcoholic hepatitis.
The most commonly reported adverse reactions in RA clinical
trials were injection site reaction and infection. In clinical
trials of all other adult indications, adverse reactions were
similar to those reported in RA clinical trials. In general, the
adverse reactions in pediatric patients were similar in frequency
and type as those seen in adult patients. The types of infections
reported in pediatric patients were generally mild and consistent
with those commonly seen in the general pediatric population.
Please see Prescribing Information and Medication Guide
at www.ENBREL.com
About Amgen
Amgen is committed to unlocking
the potential of biology for patients suffering from serious
illnesses by discovering, developing, manufacturing and delivering
innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease
and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
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Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
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and actual results may differ materially from those we project.
Discovery or identification of new product candidates or
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candidate or development of a new indication for an existing
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Further, preclinical results do not guarantee safe and effective
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human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
References:
1 National Psoriasis Foundation. Symptoms and
diagnosis. http://www.psoriasis.org/about-psoriasis/symptoms-and-diagnosis.
Accessed on October 3, 2016.
2 National Psoriasis Foundation. Frequently Asked
Questions. http://www.psoriasis.org/about-psoriasis/faqs.
Accessed on October 3, 2016.
3 International Federation of Psoriasis
Associations. Psoriasis is a Serious Disease Deserving Global
Attention: A report by the International Federation of Psoriasis
Associations. www.ifpa-pso.org/getfile.ashx?cid=279366&cc=3&refid=18.
Accessed on October 3, 2016.
4 American Academy of Dermatology.
Psoriasis. http://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis.
Last updated 2014. Accessed on October 3, 2016.
5 Raychaudhuri SP, Gross J. A comparative study of
pediatric onset psoriasis with adult onset
psoriasis.http://www.ncbi.nlm.nih.gov/pubmed/10886746 Accessed
on October 3, 2016.
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