THOUSAND OAKS, Calif.,
Nov. 7, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that it will present data from
multiple studies related to Enbrel® (etanercept),
Prolia® (denosumab) and
AMJEVITA™ (adalimumab-atto), as well as
investigational candidates, including ABP 710 (infliximab
biosimilar candidate) and romosozumab, at the American College of
Rheumatology (ACR) and Association of Rheumatology Health
Professionals (ARHP) Annual Meeting in Washington, D.C., Nov.11-16, 2016.
In addition to highlighting key data from its clinical programs,
Amgen studies will provide real-world insights on the patient
journey and related unmet needs of those living with serious
rheumatologic and bone diseases. Presentations also include
long-term data assessing the clinical and economic impact of these
diseases on patients and the overall healthcare system.
"As a leader in rheumatology and bone health, we remain
committed to not only establishing the full therapeutic potential
of our investigational products, but also to investing in continued
research of our marketed products and establishing their value,"
said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "We are
pleased to be presenting a wide breadth of data across our diverse
treatment portfolio to spark important dialogue about addressing
patient needs in devastating diseases, such as rheumatoid
arthritis, psoriatic arthritis and osteoporosis."
Romosozumab is being developed in collaboration with UCB
globally, as well as Astellas in Japan.
SELECTED ABSTRACTS OF INTEREST
Prolia Late-Breaking Abstract of Interest
- Effect of Denosumab Compared with Risedronate in
Glucocorticoid-Treated Individuals: Results from the 12-Month
Primary Analysis of a Randomized, Double-Blind, Active-Controlled
Study
Abstract 2L, ACR Late-breaking Abstract Session,
Tuesday, Nov. 15, 4:30 – 6 p.m. ET, Hall D
Prolia Oral Presentation
- Discontinuation of Denosumab and Associated Vertebral
Fracture Incidence: Analysis from a Phase 3 Placebo-Controlled
Study of Denosumab and Its Open-Label Extension
Abstract
1028, ACR Concurrent Abstract Session, Sunday, Nov. 13, 4:30 – 6
p.m. ET, 145 A
Prolia Abstracts of Interest
- Effect of 10 Years of Denosumab Treatment on
Bone Histology and Histomorphometry in the Freedom
Extension Study
Abstract 323, ACR Poster Session
A, Sunday, Nov. 13, 9 – 11 a.m. ET, Hall C
- The Risk of Subsequent Osteoporotic Fractures Is Decreased
in Patients Experiencing Fracture While on Denosumab
Abstract 336, ACR Poster Session A, Sunday,
Nov. 13, 9 – 11 a.m. ET, Hall
C
- Denosumab Treatment for 10 Years in Postmenopausal Women
with Osteoporosis Was Associated with Substantially Lower Fracture
Incidence Relative to Their Baseline FRAX-Predicted
Probability
Abstract 337, ACR Poster Session A, Sunday, Nov. 13, 9 – 11
a.m. ET, Hall C
Romosozumab Oral Presentations
- Fracture Risk Reduction with Romosozumab: Results of
a Phase 3 Study in Postmenopausal Women
with Osteoporosis
Abstract 1023, ACR Concurrent
Abstract Session, Sunday, Nov. 13,
4:30 – 6 p.m. ET, 145 A
- Superior Gains in Bone Mineral Density and Estimated
Strength at the Hip for Romosozumab Compared with Teriparatide in
Women with Postmenopausal Osteoporosis Transitioning from
Bisphosphonate Therapy: Results of a Phase 3, Open-Label Clinical
Trial
Abstract 1024, ACR Concurrent Abstract Session,
Sunday, Nov. 13, 4:30 – 6 p.m. ET, 145 A
Romosozumab Abstract of Interest
- Results of a Phase 3 Clinical Trial to Evaluate the Efficacy
and Safety of Romosozumab in Men with Osteoporosis
Abstract
321, ACR Poster Session A, Sunday, Nov.
13, 9 – 11 a.m. ET, Hall
C
ENBREL Abstracts of Interest
- Changes in the Functional Status of the Rheumatoid Arthritis
(RA) Population over the Biologic Era
Abstract 526, ACR
Poster Session A, Sunday, Nov. 13, 9
– 11 a.m. ET, Hall C
- Patient-Reported Outcomes for Etanercept Therapy in Adult
Patients with Moderate to Severe Rheumatoid Arthritis Who Failed
Adalimumab Treatment
Abstract 591, ACR Poster Session A,
Sunday, Nov. 13, 9 – 11 a.m. ET, Hall C
- Impact of Adherence to Tumor Necrosis Factor Inhibitors on
Radiographic Outcomes in US Veterans with Rheumatoid
Arthritis
Abstract 592, ACR Poster Session A, Sunday, Nov. 13, 9 – 11
a.m. ET, Hall C
- Predictors of Persistency with TNFi in Biologic-Experienced
Versus Biologic-Naive Psa Patients Enrolled in the
Corrona Registry
Abstract 1679, ACR Poster Session B,
Monday, Nov. 14, 9 – 11 a.m. ET, Hall C
- Change in Health Care Utilization after Etanercept
Initiation in Patients with Rheumatoid Arthritis
Abstract
2231, ACR Poster Session C, Tuesday, Nov.
15, 9 – 11 a.m. ET, Hall
C
- Etanercept Treatment Does Not Adversely Affect Traditional
Cardiovascular Risk Factors in Patients with Rheumatoid
Arthritis
Abstract 2579, ACR Poster Session C, Tuesday, Nov. 15, 9 – 11
a.m. ET, Hall C
- Predictors of Adherence and Costs in First and Second Years
after Biologic Initiation in Patients with Rheumatoid Arthritis
(RA)
Abstract 2233, ACR Poster Session C, Tuesday, Nov. 15, 9 – 11
a.m. ET, Hall C
- The Longitudinal Impact of Biologic Use on Disability within
a RA Registry
Abstract 2540, ACR Poster Session C,
Tuesday, Nov. 15, 9 – 11 a.m. ET, Hall C
- Impact of Biologic and Non-Biologic Treatment on the
Incidence of Traditional Cardiovascular Risk Factors Among Patients
with Rheumatoid Arthritis, Psoriatic Arthritis, or
Psoriasis
Abstract 2172, ACR Poster Session C, Tuesday, Nov. 15, 9 – 11
a.m. ET, Hall C
- Models Using Claims-Based Administrative Data Are Poor
Predictors of Rheumatoid Arthritis Disease Activity in VA
Rheumatoid Arthritis (VARA) Patients
Abstract 2230, ACR
Poster Session C, Tuesday, Nov. 15, 9
– 11 a.m. ET, Hall C
- Therapy with Biologic Agents after Diagnosis of Solid
Malignancies; Results from the Corrona Registry
Abstract
2605, ACR Poster Session C, Tuesday, Nov.
15, 9 – 11 a.m. ET, Hall
C
Biosimilar Abstracts of Interest
- ABP 501 Long-Term Safety/Efficacy: Interim Results from an
Open-Label Extension Study
Abstract 616, ACR Poster Session
A, Sunday, Nov. 13, 9 – 11 a.m. ET, Hall C
- Pharmacokinetic Similarity of ABP 710 Relative to
Infliximab: Results from a Randomized, Single-Blind, Single-Dose,
Parallel Group Study in Healthy Subjects
Abstract 615, ACR
Poster Session A, Sunday, Nov. 13, 9
– 11 a.m. ET, Hall C
About Osteoporosis
Osteoporosis affects many women
after menopause as their ability to form new bone cannot counter
balance the rate at which bone is being
removed.1,2 This bone loss leads to weakened bones
over time, increasing the potential for a break.3
It is estimated that one in three women over the age of 50 will
experience an osteoporotic fracture.4,5 Men and
women who experience an osteoporosis-related fracture are twice as
likely to experience a future fracture.6 After a
fragility fracture, nearly 1 in 4 women experienced another within
5 years.7 A prior fragility fracture is associated with
an 86 percent increased risk of another fracture in both men
and women.8
The World Health Organization has officially declared
osteoporosis a public health crisis,9,10 and
the International Osteoporosis Foundation urges
governments worldwide to make osteoporosis a healthcare
priority.11
About Prolia® (denosumab)
Prolia is
indicated for the treatment of postmenopausal women with
osteoporosis at high risk for fracture, defined as a history of
osteoporotic fracture, or multiple risk factors for fracture; or
patients who have failed or are intolerant to other available
osteoporosis therapy. In postmenopausal women with osteoporosis,
Prolia reduces the incidence of vertebral, nonvertebral, and hip
fractures.
Prolia is indicated for treatment to increase bone mass in men
with osteoporosis at high risk for fracture, defined as a history
of osteoporotic fracture, or multiple risk factors for fracture; or
patients who have failed or are intolerant to other available
osteoporosis therapy.
Prolia is indicated as a treatment to increase bone mass in men
at high risk for fracture receiving androgen deprivation therapy
for nonmetastatic prostate cancer. In these patients Prolia also
reduced the incidence of vertebral fractures.
Prolia is indicated as a treatment to increase bone mass in
women at high risk for fracture receiving adjuvant aromatase
inhibitor therapy for breast cancer.
Important Safety Information (U.S.)
Contraindications
Prolia® is
contraindicated in patients with hypocalcemia. Pre‐existing
hypocalcemia must be corrected prior to initiating
Prolia®. Prolia® is contraindicated in
women who are pregnant and may cause fetal harm.
Prolia® is contraindicated in patients with a
history of systemic hypersensitivity to any component of the
product. Reactions have included anaphylaxis, facial swelling and
urticaria.
Same Active Ingredient
Prolia® contains the same active ingredient
(denosumab) found in XGEVA®. Patients receiving
Prolia® should not receive XGEVA®.
Hypersensitivity
Clinically significant hypersensitivity including anaphylaxis has
been reported with Prolia®. Symptoms have included
hypotension, dyspnea, throat tightness, facial and upper airway
edema, pruritus, and urticaria. If an anaphylactic or other
clinically significant allergic reaction occurs, initiate
appropriate therapy and discontinue further use of
Prolia®.
Hypocalcemia
Hypocalcemia may worsen with the use of Prolia®,
especially in patients with severe renal impairment. In patients
predisposed to hypocalcemia and disturbances of mineral metabolism,
clinical monitoring of calcium and mineral levels is highly
recommended within 14 days of Prolia® injection.
Adequately supplement all patients with calcium and vitamin D.
Osteonecrosis of the Jaw (ONJ)
ONJ, which can occur spontaneously, is generally associated with
tooth extraction and/or local infection with delayed healing, and
has been reported in patients receiving Prolia®. An oral
exam should be performed by the prescriber prior to initiation of
Prolia®. A dental examination with appropriate
preventive dentistry is recommended prior to treatment in patients
with risk factors for ONJ such as invasive dental procedures,
diagnosis of cancer, concomitant therapies (e.g., chemotherapy,
corticosteroids, angiogenesis inhibitors), poor oral hygiene, and
co‐morbid disorders. Good oral hygiene practices should be
maintained during treatment with Prolia®. The risk of
ONJ may increase with duration of exposure to
Prolia®.
For patients requiring invasive dental procedures, clinical
judgment should guide the management plan of each patient. Patients
who are suspected of having or who develop ONJ should receive care
by a dentist or an oral surgeon. Extensive dental surgery to treat
ONJ may exacerbate the condition. Discontinuation of
Prolia® should be considered based on individual
benefit‐risk assessment.
Atypical Femoral Fractures
Atypical low‐energy, or low trauma fractures of the shaft have been
reported in patients receiving Prolia®. Causality has
not been established as these fractures also occur in osteoporotic
patients who have not been treated with anti‐resorptive agents.
During Prolia® treatment, patients should be
advised to report new or unusual thigh, hip, or groin pain. Any
patient who presents with thigh or groin pain should be evaluated
to rule out an incomplete femur fracture. Interruption of
Prolia®therapy should be considered, pending a
risk/benefit assessment, on an individual basis.
Serious Infections
In a clinical trial (N=7,808) in women with postmenopausal
osteoporosis, serious infections leading to hospitalization were
reported more frequently in the Prolia® group than
in the placebo group. Serious skin infections, as well as
infections of the abdomen, urinary tract and ear were more frequent
in patients treated with Prolia®.
Endocarditis was also reported more frequently in
Prolia®‐treated patients. The incidence of opportunistic
infections and the overall incidence of infections were similar
between the treatment groups. Advise patients to seek prompt
medical attention if they develop signs or symptoms of severe
infection, including cellulitis.
Patients on concomitant immunosuppressant agents or with
impaired immune systems may be at increased risk for serious
infections. In patients who develop serious infections while on
Prolia®, prescribers should assess the need for
continued Prolia® therapy.
Dermatologic Adverse Reactions
In the same clinical trial in women with postmenopausal
osteoporosis, epidermal and dermal adverse events such as
dermatitis, eczema and rashes occurred at a significantly higher
rate with Prolia® compared to placebo. Most of
these events were not specific to the injection site. Consider
discontinuing Prolia® if severe symptoms
develop.
Musculoskeletal Pain
Severe and occasionally incapacitating bone, joint, and/or muscle
pain has been reported in patients taking Prolia®.
Consider discontinuing use if severe symptoms develop.
Suppression of Bone Turnover
In clinical trials in women with postmenopausal osteoporosis,
Prolia® resulted in significant suppression of bone
remodeling as evidenced by markers of bone turnover and bone
histomorphometry. The significance of these findings and the effect
of long‐term treatment are unknown. Monitor patients for these
consequences, including ONJ, atypical fractures, and delayed
fracture healing.
Adverse Reactions
The most common adverse reactions (>5% and more common than
placebo) in women with postmenopausal osteoporosis are back pain,
pain in extremity, musculoskeletal pain, hypercholesterolemia, and
cystitis. The most common adverse reactions (> 5% and more
common than placebo) in men with osteoporosis are back pain,
arthralgia, and nasopharyngitis. Pancreatitis has been reported
with Prolia®.
In women with postmenopausal osteoporosis, the overall incidence
of new malignancies was 4.3% in the placebo group and 4.8% in the
Prolia® group. In men with osteoporosis, new
malignancies were reported in no patients in the placebo group and
4 (3.3%) patients in the Prolia® group. A causal
relationship to drug exposure has not been established.
The most common (per patient incidence ≥ 10%) adverse reactions
reported with Prolia® in patients with bone loss
receiving ADT for prostate cancer or adjuvant AI therapy for breast
cancer are arthralgia and back pain. Pain in extremity and
musculoskeletal pain have also been reported in clinical trials.
Additionally, in Prolia®‐treated men with nonmetastatic
prostate cancer receiving ADT, a greater incidence of cataracts was
observed.
Denosumab is a human monoclonal antibody. As with all
therapeutic proteins, there is potential for immunogenicity.
Prolia® Postmarketing Active Safety
Surveillance Program
The surveillance program is available
to collect information from prescribers on specific adverse events.
Please see www.proliasafety.com or call 1‐800‐772‐6436 for
more information.
For more information, please see the Prolia Prescribing
Information and Medication Guide.
About Romosozumab
Romosozumab is an investigational bone-forming monoclonal agent and
is not approved by any regulatory authority for the treatment of
osteoporosis. It is designed to work by inhibiting the activity of
the protein sclerostin and has a dual effect on bone, both
increasing bone formation and decreasing bone breakdown.
Romosozumab is being studied for its potential to reduce the risk
of fractures in an extensive global Phase 3 program. This program
includes two large fracture trials comparing romosozumab to either
placebo or active comparator in more than 10,000 postmenopausal
women with osteoporosis. Amgen and UCB are co-developing
romosozumab.
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together
under a collaboration and license agreement to research, develop
and market antibody products targeting the protein sclerostin. As
part of this agreement, the two companies continue to collaborate
on the development of romosozumab for the treatment of
osteoporosis. This gene-to-drug project demonstrates
how Amgen and UCB are joining forces to turn genetic
discoveries into new medicine, turning conceptual science into a
reality.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA)
is a chronic inflammatory disease of unknown etiology that affects
approximately one percent of the adult population
worldwide.12 RA can cause pain, stiffness, swelling and
limitations in the motion and function of multiple
joints.13 In RA, joint damage can significantly worsen
over time, especially if left untreated and may impair
function.14
About Psoriatic Arthritis
Psoriatic arthritis is an
auto-immune disease that causes pain, stiffness and swelling in and
around the joints.13 In addition, psoriatic arthritis
patients may experience skin lesions similar to those seen in
plaque psoriasis. Approximately 600,000 Americans have psoriatic
arthritis.14 In fact, up to 30 percent of people
diagnosed with plaque psoriasis may actually have psoriatic
arthritis.14
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.15,16 Approximately 125
million people worldwide have psoriasis and 80 percent of those
patients have plaque psoriasis.17,18 About
one-third of psoriasis cases are pediatric.19
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, for the
treatment of patients with ankylosing spondylitis in 2003, 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 (PsO) 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.
For more information, please see the ENBREL Prescribing
Information and Medication Guide.
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 not currently available commercially. This not
an offer for sale. The following information is derived from
the approved label.
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. This is not an offer for
sale. AMJEVITA is not currently available
commercially.
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.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
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 contained in this document as
a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products after they are
on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. We or others could identify safety, side effects or
manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations,
litigation and product liability claims. In addition, our business
may be impacted by the adoption of new tax legislation or exposure
to additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities
and also depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. The discovery of significant problems with a product
similar to one of our products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on our business and results of operations.
Our efforts to acquire other companies or products and to integrate
the operations of companies we have acquired may not be successful.
We may not be able to access the capital and credit markets on
terms that are favorable to us, or at all. We are increasingly
dependent on information technology systems, infrastructure and
data security. Our stock price is volatile and may be affected by a
number of events. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and
Drug Administration, and no conclusions can or should be drawn
regarding the safety or effectiveness of the product candidates.
Further, the scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by
the U.S. Food and Drug Administration for the products.
The products are not approved for the investigational use(s)
discussed in this news release, and no conclusions can or should be
drawn regarding the safety or effectiveness of the products for
these uses.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
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