THOUSAND OAKS, Calif.,
Nov. 17, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) announced that the ENBREL Mini™ with
AutoTouch™ is now available in the United
States (U.S.). Awarded the Arthritis Foundation Ease of
UseSM Commendation, this new and innovative delivery
system provides an additional administration option for appropriate
ENBREL patients.
The AutoTouch™ reusable autoinjector has an ergonomic design
that includes features that were designed with patients in mind,
including an ergonomic handle, a needle designed to stay hidden
during the injection, a sensor to detect placement on skin, a speed
switch with three injection speeds, a progress bar and a speaker.
The AutoTouch™ reusable autoinjector is used with ENBREL Mini™
single-dose prefilled cartridges (50 mg/mL) that utilize a new drug
formulation of ENBREL that was associated with substantially
significant lower mean injection site pain than the current
formulation.
"As a leader in the inflammation space, we continually strive to
innovate to address real needs among the patients we serve. The
first step in this is talking and listening to the community, both
patients and healthcare professionals, to fully understand the
challenges they are facing," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "These conversations highlighted the value of
features that we believe enhance the patient experience. From
there, the ENBREL Mini™ with AutoTouch™ and the new formulation,
were born."
ENBREL is an injectable biologic approved for the treatment of
several chronic conditions including moderate-to-severe rheumatoid
arthritis (RA), moderate-to-severe polyarticular juvenile
idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing
spondylitis (AS) and moderate-to-severe plaque psoriasis (PsO) in
patients four years or older.
"We are happy to award the ENBREL Mini™ cartridge with
AutoTouch™ reusable autoinjector with our Ease of UseSM
Commendation," said Cindy McDaniel,
senior vice president, Consumer Affairs, The Arthritis Foundation.
"This distinction is awarded to products proven to help people who
have arthritis and other physical limitations."
The ENBREL Mini™ with AutoTouch™ was approved by the U.S. Food
and Drug Administration in September
2017.
A Phase 3b multicenter, randomized, double-blind, crossover
study was conducted to assess the injection site pain associated
with a modified etanercept formulation in adult patients with
either moderate-to-severe RA or PsA. In addition to demonstrating a
significant reduction in injection site pain, the adverse events
were similar to those seen in previous studies in adults with
moderate-to-severe RA and PsA.
About Enbrel® (etanercept)
ENBREL is a
soluble form of a tumor necrosis factor (TNF) receptor with a
clinical efficacy and safety profile established over 19 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, in 2004 to treat
moderate-to-severe plaque psoriasis in adults, and in 2016 the
moderate-to-severe plaque psoriasis indication was expanded to
include patients 4 years or older. 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.
The use of ENBREL in patients receiving concurrent
cyclophosphamide therapy is not recommended. The risk of serious
infection may increase with concomitant use of abatacept therapy.
Concurrent therapy with ENBREL and anakinra is not recommended.
Hypoglycemia has been reported following initiation of ENBREL
therapy in patients receiving medication for diabetes,
necessitating a reduction in anti-diabetic medication in some of
these patients.
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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