THOUSAND OAKS, Calif.,
Sept. 23, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and
Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto)
across all eligible indications of the reference product,
Humira® (adalimumab). AMJEVITA is the first adalimumab
biosimilar approved by the FDA and has been approved for the
treatment of seven inflammatory diseases, including
moderate-to-severe rheumatoid arthritis, moderate-to-severe
polyarticular juvenile idiopathic arthritis, psoriatic arthritis,
ankylosing spondylitis, moderate-to-severe chronic plaque
psoriasis, adult moderate-to-severe Crohn's disease and
moderate-to-severe ulcerative colitis. AMJEVITA is Amgen's first
biosimilar to receive regulatory approval.
"Approval of AMJEVITA is an exciting accomplishment as it marks
a new chapter in Amgen's story of being a leader in biotechnology.
In addition, AMJEVITA holds the potential to offer patients with
chronic inflammatory diseases an additional treatment option," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "This milestone
exemplifies our ongoing dedication to the development of high
quality biologic medicines."
The approval of AMJEVITA was based on a comprehensive data
package supporting biosimilarity to adalimumab based on analytical,
nonclinical, pharmacokinetic and clinical data, including results
from two Phase 3 studies conducted in moderate-to-severe plaque
psoriasis and moderate-to-severe rheumatoid arthritis patients. The
Phase 3 studies each met their primary endpoint showing clinical
equivalence to adalimumab. Safety and immunogenicity of AMJEVITA
were also comparable to adalimumab.
The Company's biosimilar adalimumab is also undergoing review by
the European Medicines Agency, following a regulatory application
submitted in December 2015.
Biosimilar adalimumab is one of nine programs included in Amgen's
robust pipeline of biosimilars.
About AMJEVITA™ (adalimumab-atto) in the U.S.
AMJEVITA is a biosimilar to adalimumab, an anti-TNF-α monoclonal
antibody. The active ingredient of AMJEVITA is an anti-TNF-α
monoclonal antibody that has the same amino acid sequence as, and
is highly similar to, adalimumab. AMJEVITA will be delivered in
prefilled syringe and autoinjector presentations to support dosing
in each of the approved indications.
AMJEVITA is indicated, alone or in combination with methotrexate
or other non-biologic DMARDs, for reducing signs and symptoms,
inducing major clinical response, inhibiting the progression of
structural damage, and improving physical function in adult
patients with moderately to severely active rheumatoid
arthritis.
AMJEVITA is indicated, alone or in combination with
methotrexate, for reducing signs and symptoms of moderately to
severely active polyarticular juvenile idiopathic arthritis in
patients 4 years of age and older.
AMJEVITA is indicated, alone or in combination with non-biologic
DMARDs, for reducing signs and symptoms, inhibiting the progression
of structural damage, and improving physical function in adult
patients with active psoriatic arthritis.
AMJEVITA is indicated for reducing signs and symptoms in adult
patients with active ankylosing spondylitis.
AMJEVITA is indicated for reducing signs and symptoms and
inducing and maintaining clinical remission in adult patients with
moderately to severely active Crohn's disease who have had an
inadequate response to conventional therapy, and reducing signs and
symptoms and inducing clinical remission in these patients if they
have also lost response to or are intolerant to infliximab.
AMJEVITA is indicated for inducing and sustaining clinical
remission in adult patients with moderately to severely active
ulcerative colitis who have had an inadequate response to
immunosuppressants such as corticosteroids, azathioprine, or
6-mercaptopurine. The effectiveness of adalimumab products has not
been established in patients who have lost response to or were
intolerant to TNF blockers.
AMJEVITA is indicated for the treatment of adult patients with
moderate to severe chronic plaque psoriasis who are candidates for
systemic therapy or phototherapy, and when other systemic therapies
are medically less appropriate. AMJEVITA should only be
administered to patients who will be closely monitored and have
regular follow-up visits with a physician.
AMJEVITA™ U.S. Important Safety Information
SERIOUS INFECTIONS
Patients treated with AMJEVITA™
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.
Discontinue AMJEVITA™
if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis (TB), including reactivation of latent
TB. Patients with TB have frequently presented with disseminated or
extrapulmonary disease. Test patients for latent TB before
AMJEVITA™ use and during therapy. Initiate treatment for latent TB
prior to AMJEVITA™ use.
- 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. Consider
empiric anti-fungal therapy in patients at risk for invasive fungal
infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic
pathogens, including Legionella and Listeria.
Carefully consider the risks and benefits of treatment with
AMJEVITA™ prior to initiating therapy in patients: 1. with chronic
or recurrent infection, 2. who have been exposed to TB, 3. with a
history of opportunistic infection, 4. who resided in or traveled
in regions where mycoses are endemic, 5. with underlying conditions
that may predispose them to infection. Monitor patients closely for
the development of signs and symptoms of infection during and after
treatment with AMJEVITA™, including the possible development of TB
in patients who tested negative for latent TB infection prior to
initiating therapy.
- Do not start AMJEVITA™ during an active infection, including
localized infections.
- Patients older than 65 years, patients with co-morbid
conditions, and/or patients taking concomitant immunosuppressants
may be at greater risk of infection.
- If an infection develops, monitor carefully and initiate
appropriate therapy.
- Drug interactions with biologic products: A higher rate of
serious infections has been observed in rheumatoid arthritis
patients treated with rituximab who received subsequent treatment
with a TNF blocker. Concurrent use of AMJEVITA™ with biologic
DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not
recommended based on the possible increased risk for infections and
other potential pharmacological interactions.
MALIGNANCY
Lymphoma and other malignancies, some
fatal, have been reported in children and adolescent patients
treated with TNF blockers including adalimumab products.
Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a
rare type of T-cell lymphoma, have been reported in patients
treated with TNF blockers including adalimumab products. These
cases have had a very aggressive disease course and have been
fatal. The majority of reported TNF blocker cases have occurred in
patients with Crohn's disease or ulcerative colitis and the
majority were in adolescent and young adult males. Almost all of
these patients had received treatment with azathioprine or
6-mercaptopurine concomitantly with a TNF blocker at or prior to
diagnosis. It is uncertain whether the occurrence of HSTCL is
related to use of a TNF blocker or a TNF blocker in combination
with these other immunosuppressants.
- Consider the risks and benefits of TNF-blocker treatment prior
to initiating or continuing therapy in a patient with known
malignancy.
- In clinical trials of some TNF-blockers, including adalimumab
products, more cases of malignancies were observed among
TNF-blocker-treated patients compared to control patients.
- Non-melanoma skin cancer (NMSC) was reported during clinical
trials for adalimumab-treated patients. Examine all patients,
particularly those with a history of prolonged immunosuppressant or
PUVA therapy, for the presence of NMSC prior to and during
treatment with AMJEVITA™.
- In adalimumab clinical trials, there was an approximate 3-fold
higher rate of lymphoma than expected in the general U.S.
population. Patients with chronic inflammatory diseases,
particularly those with highly active disease and/or chronic
exposure to immunosuppressant therapies, may be at higher risk of
lymphoma than the general population, even in the absence of TNF
blockers.
- Postmarketing cases of acute and chronic leukemia were reported
with TNF blocker use. Approximately half of the postmarketing cases
of malignancies in children, adolescents, and young adults
receiving TNF blockers were lymphomas; other cases included rare
malignancies associated with immunosuppression and malignancies not
usually observed in children and adolescents.
HYPERSENSITIVITY
Anaphylaxis and angioneurotic edema
have been reported following administration of adalimumab products.
If a serious allergic reaction occurs, stop AMJEVITA™ and institute
appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers,
including AMJEVITA™, may increase the risk of reactivation of
hepatitis B virus (HBV) in patients who are chronic carriers. Some
cases have been fatal. Evaluate patients at risk for HBV
infection for prior evidence of HBV infection before initiating TNF
blocker therapy. Exercise caution in patients who are carriers of
HBV and monitor them during and after AMJEVITA™ treatment.
Discontinue AMJEVITA™ and begin antiviral therapy in patients who
develop HBV reactivation. Exercise caution when resuming AMJEVITA™
after HBV treatment.
NEUROLOGIC REACTIONS
TNF blockers, including
adalimumab products, have been associated with rare cases of new
onset or exacerbation of central nervous system and peripheral
demyelinating diseases, including multiple sclerosis, optic
neuritis, and Guillain-Barré syndrome. Exercise caution when
considering AMJEVITA™ for patients with these disorders;
discontinuation of AMJEVITA™ should be considered if any of these
disorders develop.
HEMATOLOGICAL REACTIONS
Rare reports of pancytopenia,
including aplastic anemia, have been reported with TNF blockers.
Medically significant cytopenia has been infrequently reported with
adalimumab products. Consider stopping AMJEVITA™ if significant
hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
Worsening or new onset
congestive heart failure (CHF) may occur; exercise caution and
monitor carefully.
AUTOIMMUNITY
Treatment with adalimumab products may
result in the formation of autoantibodies and, rarely, in
development of a lupus-like syndrome. Discontinue treatment if
symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
Patients on AMJEVITA™ should not receive
live vaccines. Pediatric patients, if possible, should be brought
up to date with all immunizations before initiating AMJEVITA™
therapy. The safety of administering live or live-attenuated
vaccines in infants exposed to adalimumab products in utero is
unknown. Risks and benefits should be considered prior to
vaccinating (live or live-attenuated) exposed infants.
ADVERSE REACTIONS
The most common adverse reactions in
adalimumab clinical trials (>10%) were: infections (e.g., upper
respiratory, sinusitis), injection site reactions, headache, and
rash.
Please see full Prescribing Information, including Medication
Guide.
About Amgen Biosimilars
Amgen Biosimilars is committed
to building upon Amgen's experience in the development
and manufacturing of innovative human therapeutics to
expand Amgen's reach to patients with serious illnesses.
Biosimilars will help to maintain Amgen's commitment to connect
patients with vital medicines, and Amgen is well
positioned to leverage its more than 35 years of experience in
biotechnology to create high quality biosimilars and reliably
supply them to patients worldwide.
For more information,
visit www.amgenbiosimilars.com and follow us on
www.twitter.com/amgenbiosim.
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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CONTACT: Amgen, Thousand
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