Breadth of Research Reflects Amgen's
Commitment to Rheumatology
Data Include Sjögren's Syndrome, Uncontrolled
Gout, Severe Active ANCA-Associated Vasculitis and Psoriatic
Arthritis
THOUSAND
OAKS, Calif., Nov. 1, 2023
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the
presentation of new scientific and clinical research across its
expanded rheumatology pipeline and portfolio, following the recent
acquisition of Horizon Therapeutics. More than 20 abstracts will be
presented during the American College of Rheumatology (ACR)
Convergence 2023, taking place Nov.
10-15, in San Diego.
"The data at ACR will illustrate our continued growth in
rheumatology as we advance unique treatment approaches across
a broader range of diseases," said David M.
Reese, M.D., executive vice president of Research and
Development at Amgen. "Drawing on our decades of experience in
inflammation, we're looking forward to advancing new treatment
areas like Sjögren's syndrome and uncontrolled gout."
At ACR, new results will be presented from the Phase 2 study of
dazodalibep, an investigational therapy for Sjögren's. Other
research highlights include new TAVNEOS® (avacopan) data
from the Phase 3 ADVOCATE study evaluating diffuse alveolar
hemorrhage (DAH) in patients with severe active ANCA-associated
vasculitis (GPA/MPA), as well as an oral presentation on
Otezla® (apremilast) in FOREMOST, the first
placebo-controlled study designed to specifically assess people
with early oligoarticular psoriatic arthritis. Additionally, new
real-world data showing a significant uptake in the use of
KRYSTEXXA® (pegloticase) with methotrexate or other
immunomodulators by clinicians following the U.S. labeling update,
will be delivered at the meeting.
Abstracts and Presentation Times:
Amgen Sponsored Abstracts
AMJEVITA® (adalimumab-atto)
- Pharmacokinetic and Safety Similarity of High- and
Low-Concentration Formulations of Adalimumab Biosimilar ABP
501
Abstract #2161, Poster Session C: RA – Treatments
Poster III, Tuesday, Nov. 14 from
9-11am PST
Enbrel® (etanercept)
- Outcomes in Patients With Rheumatoid Arthritis Initiating
Therapy With Etanercept, Adalimumab, or Janus Kinase
Inhibitors
Abstract #0441, Poster Session A: RA – Treatments
Poster I, Sunday, Nov. 12 from 9-11am
PST
KRYSTEXXA® (pegloticase)
- Treatment-Emergent Major Adverse Cardiovascular and
Thromboembolic Events Were Infrequent During Pegloticase Therapy:
Pooled Clinical Trial Findings
Abstract #0236, Poster Session A: Metabolic & Crystal
Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
- Oral Urate-Lowering Therapy Use and Efficacy Following
Pegloticase Treatment: Findings from a Rheumatology Network
Database
Abstract #0237, Poster Session A: Metabolic & Crystal
Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
- Incidence and Prevalence of Cardiovascular and Metabolic
Diseases Following Gout Diagnosis in the United Kingdom Using the
THIN Database
Abstract #0239, Poster Session A: Metabolic & Crystal
Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
- Venous Thromboembolism in Patients with Gout in the
US
Abstract #0242, Poster Session A: Metabolic & Crystal
Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
- Finding Lost-to-Care Gout Patients in a Large Community
Rheumatology Network: Patient Re-engagement Initiative with Metrics
(PRIME)
Abstract #1102, Poster Session B: Metabolic &
Crystal Arthropathies – Basic & Clinical Science Poster II,
Monday, Nov. 13 from 9-11am PST
- Evaluation of Outcomes Following Discontinuation of
Pegloticase Therapy
Abstract #1103, Poster Session B: Metabolic & Crystal
Arthropathies – Basic & Clinical Science Poster II,
Monday, Nov. 13 from 9-11am PST
- Predictors of Pegloticase Urate-lowering Response in the
Presence and Absence of Methotrexate Co-therapy
Abstract #1107, Poster Session B: Metabolic & Crystal
Arthropathies – Basic & Clinical Science Poster II,
Monday, Nov. 13 from 9-11am PST
- Minimal Clinically Important Difference (MCID) of Quality of
Life Assessments in Patients with Uncontrolled Gout
Abstract #1108, Poster Session B: Metabolic & Crystal
Arthropathies – Basic & Clinical Science Poster II,
Monday, Nov. 13 from 9-11am PST
- Real-world Trends in the Use of Immunomodulation as
Co-Therapy to Pegloticase: Claims-Based Findings Since 2016
Abstract #1123, Poster Session B: Metabolic & Crystal
Arthropathies – Basic & Clinical Science Poster II,
Monday, Nov. 13 from 9-11am PST
- Human Cardiovascular Disease Model Provides Transcriptomic
Evidence of Cardiovascular Risk Associated With Febuxostat
Abstract #1145, Poster Session B: Miscellaneous Rheumatic &
Inflammatory Diseases Poster II, Monday,
Nov. 13 from 9-11am PST
- Understanding Community Perspectives on Disease Management:
A Social Media Analysis of Gout Care Strategies
Abstract #1204, Poster Session B: Patient Outcomes, Preferences,
& Attitudes Poster II, Monday, Nov.
13 from 9-11am PST
Otezla® (apremilast)
- 16-Week Results from FOREMOST, a Placebo-Controlled Study
Involving Oligoarticular Psoriatic Arthritis Treated With
Apremilast
Abstract #1691, Oral Abstract Session:
Spondyloarthritis Including Psoriatic Arthritis – Treatment II:
PsA, Monday Nov. 13 from 5-5:10pm PST
- Apremilast Reduces Inflammation as Measured by MRI of the
Hand in Patients With Psoriatic Arthritis: Primary Results from the
Phase 4 MOSAIC Study
Abstract #1690, Oral Abstract Session: Spondyloarthritis Including
Psoriatic Arthritis – Treatment II: PsA, Monday Nov. 13 from 4:45-4:55pm PST
- The Burden of Oligoarticular Psoriatic Arthritis in
the United States
Abstract
#0966, Poster Session B: Epidemiology & Public Health Poster
II, Monday Nov. 13 from
9-11am PST
- Efficacy of Apremilast on Peripheral and Axial Inflammation
in Patients With Psoriatic Arthritis Based on Whole-Body Magnetic
Resonance Imaging
Abstract #1041, Poster Session B: Imaging
of Rheumatic Diseases Poster I, Monday Nov. 13 from 9-11am
PST
- Effect of Apremilast Treatment on the Domains of MDA-Joints
in Patients With Early Oligoarticular Psoriatic Arthritis: 16-Week
Results From FOREMOST
Abstract #1413, Poster Session B:
Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster
II: SpA, Monday Nov. 13 from
9-11am PST
- Effects of Apremilast on Changes in Cardiometabolic
Parameters by Diabetes and Obesity Status in Patients with
Psoriatic Arthritis
Abstract #1414, Poster Session B:
Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster
II: SpA, Monday Nov. 13 from
9-11am PST
Prolia® (denosumab)
- Current Trends in the Risk of Subsequent Fracture After
Initial Fracture, and Post-Fracture Treatment Among Commercially
Insured Postmenopausal Women in the
United States
Abstract #2528, Oral Abstract Session:
Osteoporosis & Metabolic Bone Disease – Basic & Clinical
Science, Tuesday, Nov. 14 from
4:15-4:25pm PST
- Comparative Effectiveness of Denosumab versus Zoledronic
Acid Among Postmenopausal Women with Osteoporosis in the U.S.
Medicare Program
Abstract #2529, Oral Abstract Session:
Osteoporosis & Metabolic Bone Disease – Basic & Clinical
Science, Tuesday, Nov. 14 from
4:30-4:40pm PST
- Comparative Effectiveness of Denosumab versus Alendronate
among Postmenopausal Women with Osteoporosis in the U.S. Medicare
Program
Abstract #2008, Poster Session C: Osteoporosis &
Metabolic Bone Disease – Basic & Clinical Science Poster,
Tuesday, Nov. 14 from 9-11am PST
TAVNEOS® (avacopan)
- Change in Albuminuria in Patients with ANCA-Associated
Vasculitis Treated with Avacopan
Abstract #0857, Oral
Abstract Session: Vasculitis – ANCA-Associated I, Sunday, Nov. 12 from 5-5:15pm PST
- Remission, Glucocorticoid Toxicity, Health-Related Quality
of Life, and Safety Outcomes in Patients with Renal Involvement in
the Phase 3 Trial of Avacopan for the Treatment of ANCA-Associated
Vasculitis
Abstract #0683, Poster Session A: Vasculitis –
ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
- Report on Twelve Patients with Diffuse Alveolar Hemorrhage
in the Phase 3 Trial of Avacopan for the Treatment of
ANCA-Associated Vasculitis
Abstract #0684, Poster Session A:
Vasculitis – ANCA-Associated Poster I: Treatment Outcomes,
Sunday, Nov. 12 from 9-11am PST
- Efficacy and Safety of Avacopan in Patients Receiving
Rituximab in a Phase 3 Trial
Abstract #0685, Poster Session
A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes,
Sunday, Nov. 12 from 9-11am PST
- Safety and Efficacy of Avacopan in Patients 65 Years and
Older with ANCA-Associated Vasculitis
Abstract #0686, Poster
Session A: Vasculitis – ANCA-Associated Poster I: Treatment
Outcomes, Sunday, Nov. 12 from
9-11am PST
- A Real-World Descriptive Study of Renal Outcomes Among
Patients with ANCA-Associated Vasculitis Initiating Remission
Induction Therapy
Abstract #2379, Poster Session C:
Vasculitis – ANCA-Associated Poster III: Biomarkers & Renal
Outcomes, Tuesday, Nov. 14 from
9-11am PST
AMG 570 (rozibafusp alfa)
- A Conceptual Framework to Characterize the Indirect Burden
of Systemic Lupus Erythematosus (SLE): Findings from Qualitative
Patient Interviews
Abstract #0171, Poster Session A: Health
Services Research Poster I, Sunday, Nov.
12 from 9-11am PST
Dazodalibep
- Dazodalibep, a CD40L Antagonist, in Subjects with Sjögren's
Having Moderate-to-Severe Systemic Disease Activity: Full Crossover
Results from a Phase 2, Randomized, Double-Blind,
Placebo-Controlled, Proof of Concept Study
Abstract #1636, Oral Abstract Session: Sjögren's Syndrome – Basic
& Clinical Science, Monday, Nov.
13 from 2-3:30pm PST
- Dazodalibep, a CD40L Antagonist, in a Phase 2, Randomized,
Double-Blind, Placebo-Controlled, Crossover Trial of Subjects with
Sjögren's Disease Having Unacceptable Symptomatic Burden but
Limited Extraglandular Organ Involvement
Abstract #L10,
Late-Breaking Abstract Posters: Poster Session C, Tuesday, Nov. 14 from 9-11
am PST
- CD40L Inhibition with Dazodalibep Rapidly Reduces Blood
Biomarkers of T and B Cell Costimulation in Subjects with Sjögren's
Having High Disease Activity or High Symptom Burden
Abstract #1638, Oral Abstract Session: Sjögren's Syndrome – Basic
& Clinical Science, Monday, Nov.
13 from 2-3:30pm PST
- Treatment Patterns and Drivers of Biologic Prescriptions in
Patients with Primary Sjögren's Disease: Results from a
Multinational, Real-World Survey
Abstract #1369, Poster Session B: Sjögren's Syndrome – Basic &
Clinical Science Poster I, Monday, Nov.
13 from 9-11am PST
- Population Pharmacokinetic/Pharmacodynamic Modeling of
Dazodalibep, a CD40L Antagonist, in Healthy Volunteers and Patients
with Rheumatoid Arthritis and Sjögren's Syndrome
Abstract
#1379, Poster Session B: Sjögren's Syndrome – Basic & Clinical
Science Poster I, Monday, Nov. 13
from 9-11am PST
- Disease Burden of Patients with Primary Sjögren's Disease:
Results from a Multinational Real-World Survey
Abstract #2179, Poster Session C: Sjögren's Syndrome – Basic &
Clinical Science Poster II, Tuesday, Nov.
14 from 9-11am PST
Partner-Led Abstracts
EVENITY® (romosozumab-aqqg)
- Osteoporosis Treatment Attributes and Levels for an Online
Decision-Making Tool for Patients: Findings from Adaptive
Choice-Based Conjoint Analysis
Abstract #2025, Poster
Session C: Patient Outcomes, Preferences, & Attitudes Poster
III, Tuesday, Nov. 14 from
9-11am PST
TAVNEOS® (avacopan)
- Efficacy and Safety Experience with Avacopan Beyond 52 Weeks
in the Early Access Program (EAP)
Abstract #0688, Poster
Session A: Vasculitis – ANCA-Associated Poster I: Treatment
Outcomes, Sunday, Nov. 12 from
9-11am PST
About KRYSTEXXA®
(pegloticase)
KRYSTEXXA® (pegloticase) is the first and only
biologic approved by the FDA to treat adults living with
uncontrolled gout, a painful and debilitating inflammatory
condition with which people continue to have abnormally high levels
of uric acid and symptoms despite the use of conventional
therapies.
In 2022, the FDA approved expanding labeling to include
co-administration with the immunomodulator methotrexate, based on
results from the MIRROR randomized controlled trial, which showed
significant improvements in efficacy and safety, including a
reduction in infusion reactions.
About Uncontrolled Gout
Gout is a chronic, progressive inflammatory form of arthritis that
is caused by high urate levels in the body. Tiny needle-like
crystals can form and build up almost anywhere in the body.
Patients with uncontrolled gout continue to have high levels of
uric acid and ongoing symptoms of gout despite the use of oral
urate-lowering therapies. Uncontrolled gout is a chronic, systemic
disease, and if not addressed can have significant clinical
consequences.
KRYSTEXXA INDICATION
KRYSTEXXA (pegloticase) is indicated for the treatment of chronic
gout in adult patients who have failed to normalize serum uric acid
and whose signs and symptoms are inadequately controlled with
xanthine oxidase inhibitors at the maximum medically appropriate
dose or for whom these drugs are contraindicated.
Limitations of Use: KRYSTEXXA is not recommended for the
treatment of asymptomatic hyperuricemia.
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY
ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA
- Anaphylaxis and infusion reactions have been reported to
occur during and after administration of KRYSTEXXA.
- Anaphylaxis may occur with any infusion, including a first
infusion and generally manifests within 2 hours of the infusion.
Delayed hypersensitivity reactions have also been
reported.
- KRYSTEXXA should be administered in healthcare settings and
by healthcare providers prepared to manage anaphylaxis and infusion
reactions.
- Patients should be premedicated with antihistamines and
corticosteroids and closely monitored for anaphylaxis for an
appropriate period after administration of KRYSTEXXA.
- Serum uric acid levels should be monitored prior to each
infusion and treatment discontinued if levels increase to above 6
mg/dL, particularly when 2 consecutive levels above 6 mg/dL are
observed.
- Patients at risk for glucose-6-phosphate dehydrogenase
(G6PD) deficiency should be screened prior to starting KRYSTEXXA.
Hemolysis and methemoglobinemia have been reported with KRYSTEXXA
in patients with G6PD deficiency. KRYSTEXXA is contraindicated in
patients with G6PD deficiency.
CONTRAINDICATIONS
- In patients with G6PD deficiency.
- In patients with history of serious hypersensitivity reactions,
including anaphylaxis, to KRYSTEXXA or any of its components.
WARNINGS AND PRECAUTIONS
Gout Flares: An increase in gout flares is
frequently observed upon initiation of anti-hyperuricemic therapy,
including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal
anti-inflammatory drug (NSAID) or colchicine is recommended
starting at least 1 week before initiation of KRYSTEXXA therapy and
lasting at least 6 months, unless medically contraindicated or not
tolerated.
Congestive Heart Failure: KRYSTEXXA has not been
formally studied in patients with congestive heart failure, but
some patients in the pre-marketing placebo-controlled clinical
trials experienced exacerbation. Caution should be exercised in
patients who have congestive heart failure and patients should be
closely monitored following infusion.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5%) are:
- KRYSTEXXA co-administration with methotrexate
trial: gout flares, arthralgia, COVID-19, nausea and
fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19,
nausea, fatigue, infusion reactions, pain in extremity,
hypertension and vomiting.
- KRYSTEXXA pre-marketing placebo-controlled
trials: gout flares, infusion reactions, nausea, contusion
or ecchymosis, nasopharyngitis, constipation, chest pain,
anaphylaxis and vomiting.
Please see Full Prescribing
Information, including Boxed Warning.
About Otezla®
(apremilast)
Otezla® (apremilast) is an oral
small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for
cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in
increased intracellular cAMP levels, which is thought to indirectly
modulate the production of inflammatory mediators. The specific
mechanism(s) by which Otezla exerts its therapeutic action in
patients is not well defined.
Since its initial FDA approval in 2014, Otezla has been
prescribed to more than 840,000 patients worldwide.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic, inflammatory form of arthritis,
which can cause swelling, stiffness and pain in and around the
joints that worsens over time and can decrease physical function.
It is estimated that nearly 38 million people worldwide have
psoriatic arthritis. Around a third of people living with psoriasis
may go on to develop psoriatic arthritis. If left untreated,
psoriatic arthritis can cause disability.
Otezla U.S. INDICATIONS
Otezla (apremilast)
is indicated for the treatment of adult patients with plaque
psoriasis who are candidates for phototherapy or systemic
therapy.
Otezla is indicated for the treatment of adult patients with
active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with
oral ulcers associated with Behçet's Disease.
Otezla U.S. IMPORTANT SAFETY INFORMATION
Contraindications
- Otezla is contraindicated in patients with a known
hypersensitivity to apremilast or to any of the excipients in the
formulation
Warnings and Precautions
- Hypersensitivity: Hypersensitivity reactions, including
angioedema and anaphylaxis, have been reported during postmarketing
surveillance. If signs or symptoms of serious hypersensitivity
reactions occur, discontinue Otezla and institute appropriate
therapy
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea,
nausea, and vomiting were associated with the use of Otezla. Most
events occurred within the first few weeks of treatment. In some
cases, patients were hospitalized. Patients 65 years of age or
older and patients taking medications that can lead to volume
depletion or hypotension may be at a higher risk of complications
from severe diarrhea, nausea, or vomiting. Monitor patients who are
more susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider Otezla dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
- Depression: Carefully weigh the risks and benefits of treatment
with Otezla for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on Otezla. Patients, caregivers, and families should
be advised of the need to be alert for the emergence or worsening
of depression, suicidal thoughts or other mood changes, and they
should contact their healthcare provider if such changes occur
-
- Plaque Psoriasis: Treatment with Otezla is associated with an
increase in depression. During clinical trials in patients with
moderate to severe plaque psoriasis, 1.3% (12/920) of patients
reported depression compared to 0.4% (2/506) on placebo. Depression
was reported as serious in 0.1% (1/1308) of patients exposed to
Otezla, compared to none in placebo-treated patients (0/506).
Suicidal behavior was observed in 0.1% (1/1308) of patients on
Otezla, compared to 0.2% (1/506) on placebo. One patient treated
with Otezla attempted suicide; one patient on placebo committed
suicide
- Psoriatic Arthritis: Treatment with Otezla is associated with
an increase in depression. During clinical trials, 1.0% (10/998)
reported depression or depressed mood compared to 0.8% (4/495)
treated with placebo. Suicidal ideation and behavior was observed
in 0.2% (3/1441) of patients on Otezla, compared to none in
placebo-treated patients. Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in
placebo-treated patients (0/495). Two patients who received placebo
committed suicide compared to none on Otezla
- Behçet's Disease: Treatment with Otezla is associated with an
increase in depression. During the clinical trial, 1% (1/104)
reported depression or depressed mood compared to 1% (1/103)
treated with placebo. No instances of suicidal ideation or behavior
were reported in patients treated with Otezla or treated with
placebo
- Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla
-
- Plaque Psoriasis: Body weight loss of 5-10% occurred in 12%
(96/784) of patients with moderate to severe plaque psoriasis
treated with Otezla and in 5% (19/382) of patients treated with
placebo. Body weight loss of ≥10% occurred in 2% (16/784) of
patients treated with Otezla compared to 1% (3/382) of patients
treated with placebo
- Psoriatic Arthritis: Body weight loss of 5-10% was reported in
10% (49/497) of patients taking Otezla and in 3.3% (16/495) of
patients taking placebo
- Behçet's Disease: Body weight loss of >5% was reported in
4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of
patients taking placebo
- Drug Interactions: Apremilast exposure was decreased when
Otezla was co-administered with rifampin, a
strong CYP450 enzyme inducer; loss of Otezla efficacy may
occur. Concomitant use of Otezla with CYP450 enzyme
inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin)
is not recommended
Adverse Reactions
- Plaque Psoriasis: The most common adverse reactions (≥ 5%) are
diarrhea, nausea, upper respiratory tract infection, and headache,
including tension headache. Overall, the safety profile of Otezla
in patients with mild to moderate plaque psoriasis was consistent
with the safety profile previously established in adult patients
with moderate to severe plaque psoriasis
- Psoriatic Arthritis: The most common adverse reactions (≥ 5%)
are diarrhea, nausea, and headache
- Behçet's Disease: The most common adverse reactions (≥ 10%) are
diarrhea, nausea, headache, and upper respiratory tract
infection.
Use in Specific Populations
- Otezla has not been studied in pregnant women. Advise pregnant
women of the potential risk of fetal loss.
Please click here for
Otezla® Full Prescribing Information.
About TAVNEOS® (avacopan)
TAVNEOS® (avacopan), approved by the FDA as an
adjunctive treatment of severe active ANCA-associated vasculitis
(GPA/MPA), is a first-in-class, orally administered small molecule
that employs a novel, highly targeted mode of action. While the
precise mechanism in ANCA-associated vasculitis (GPA/MPA) has not
been definitively established, TAVNEOS, by blocking the complement
5a receptor (C5aR) for the pro-inflammatory complement system
fragment known as C5a on destructive inflammatory cells such as
blood neutrophils, is presumed to arrest the ability of those cells
to do damage in response to C5a activation, which is known to be a
driver of ANCA-associated vasculitis (GPA/MPA).
About ANCA-Associated Vasculitis
ANCA-associated
vasculitis is an umbrella term for a group of multi-system
autoimmune diseases with small vessel inflammation. Inflamed
vessels may rupture or become occluded giving rise to a broad array
of clinical symptoms and signs related to a systemic inflammatory
response which may result in profound impairment in the kidneys,
lungs and other organs. Prior to the approval of TAVNEOS in severe
active ANCA-associated vasculitis, treatment for ANCA-associated
vasculitis was limited to courses of immuno-suppressants
(cyclophosphamide or rituximab), combined with the administration
of daily glucocorticoids (steroids) for prolonged periods of time,
which can be associated with significant clinical consequences.
TAVNEOS U.S. PRESCRIBING INFORMATION
TAVNEOS is
indicated as an adjunctive treatment of adult patients with severe
active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated
vasculitis (granulomatosis with polyangiitis [GPA] and microscopic
polyangiitis [MPA]) in combination with standard therapy including
glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
TAVNEOS U.S. IMPORTANT SAFETY INFORMATION
Contraindications
Serious hypersensitivity to avacopan or to any of the
excipients.
Warning and Precautions
Hepatotoxicity: Serious cases of hepatic injury have been
observed in patients taking TAVNEOS, including life-threatening
events. Obtain liver test panel before initiating TAVNEOS, every 4
weeks after start of therapy for six months and as clinically
indicated thereafter. Monitor patients closely for hepatic adverse
reactions, and consider pausing or discontinuing treatment as
clinically indicated (refer to section 5.1 of the Prescribing
Information). TAVNEOS is not recommended for patients with active,
untreated and/or uncontrolled chronic liver disease (e.g., chronic
active hepatitis B, untreated hepatitis C, uncontrolled autoimmune
hepatitis) and cirrhosis. Consider the risk and benefit before
administering this drug to a patient with liver disease.
Serious Hypersensitivity Reactions: Cases of angioedema occurred
in a clinical trial, including one serious event requiring
hospitalization. Discontinue immediately if angioedema occurs and
manage accordingly. TAVNEOS must not be re-administered unless
another cause has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation,
including life threatening hepatitis B, was observed in the
clinical program. Screen patients for HBV. For patients with
evidence of prior infection, consult with physicians with expertise
in HBV and monitor during TAVNEOS therapy and for six months
following. If patients develop HBV reactivation, immediately
discontinue TAVNEOS and concomitant therapies associated with HBV
reactivation, and consult with experts before resuming.
Serious Infections: Serious infections, including fatal
infections, have been reported in patients receiving TAVNEOS. The
most common serious infections reported in TAVNEOS group were
pneumonia and urinary tract infections. Avoid use of TAVNEOS in
patients with active, serious infection, including localized
infections. Consider the risks and benefits before initiating
TAVNEOS in patients with chronic infection, at increased risk of
infection or who have been to places where certain infections are
common.
Adverse Reactions
The most common adverse reactions (≥5% of patients and higher in
the TAVNEOS group vs. prednisone group) were: nausea, headache,
hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal
pain, dizziness, blood creatinine increased, and paresthesia.
Drug Interactions
Avoid coadministration of TAVNEOS with strong and moderate
CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered
with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor
for adverse reactions and consider dose reduction of certain
sensitive CYP3A4 substrates.
Please see Full Prescribing
Information and Medication Guide.
About Dazodalibep
Dazodalibep is a CD40 ligand
antagonist that blocks T cell interaction with CD40-expressing B
cells, disrupting the overactivation of the CD40 ligand
co-stimulatory pathway. Several autoimmune diseases are associated
with the overactivation of this pathway. Amgen also plans to
investigate dazodalibep in focal segmental glomerulosclerosis, a
rare kidney disorder characterized by scarring of glomeruli.
About Sjögren's Syndrome
Sjögren's syndrome is a
chronic, systemic autoimmune disease affecting exocrine glands,
primarily the salivary and tear glands, with severe cases affecting
multiple organs. Like other autoimmune diseases, Sjögren's syndrome
primarily affects women. The disease also has an increased risk of
non-Hodgkin's B-cell lymphoma and there is an unmet medical need
for patients with extraglandular disease manifestations, as
currently there is no therapy that can improve or slow the course
of the disease. Disease manifestations include dry mouth, dry eyes,
arthritis and kidney or lung dysfunction.
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.
Amgen is one of the 30 companies that comprise the Dow
Jones Industrial Average and is also part of the Nasdaq-100 index.
In 2023, Amgen was named one of "America's Greatest Workplaces" by
Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best
Companies" by TIME.
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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 any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company (including BeiGene, Ltd. or
Kyowa-Kirin Co., Ltd.), the performance of Otezla® (apremilast)
(including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), the Teneobio, Inc. acquisition, the
ChemoCentryx, Inc. acquisition, or the Horizon Therapeutics plc
acquisition (including the prospective performance and outlook of
Horizon's business, performance and opportunities and any potential
strategic benefits, synergies or opportunities expected as a result
of such acquisition), as well as 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, effects of
pandemics or other widespread health problems on our business,
outcomes, progress, 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 current reports on
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, including our devices, 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. 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, including in Puerto Rico, 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. An outbreak of disease or similar public
health threat, such as COVID-19, and the public and governmental
effort to mitigate against the spread of such disease, could have a
significant adverse effect on the supply of materials for our
manufacturing activities, the distribution of our products, the
commercialization of our product candidates, and our clinical trial
operations, and any such events may have a material adverse effect
on our product development, product sales, business and results of
operations. We rely on collaborations with third parties for the
development of some of our product candidates and for the
commercialization and sales of some of our commercial products. 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. Certain of our distributors, customers and payers have
substantial purchasing leverage in their dealings with us. 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 collaborate
with or acquire other companies, products or technology, and to
integrate the operations of companies or to support the products or
technology we have acquired, may not be successful. There can be no
guarantee that we will be able to realize any of the strategic
benefits, synergies or opportunities arising from the Horizon
acquisition, and such benefits, synergies or opportunities may take
longer to realize than expected. We may not be able to
successfully integrate Horizon, and such integration may take
longer, be more difficult or cost more than expected. A breakdown,
cyberattack or information security breach of our information
technology systems could compromise the confidentiality, integrity
and availability of our systems and our data. Our stock price is
volatile and may be affected by a number of events. Our business
and operations may be negatively affected by the failure, or
perceived failure, of achieving our environmental, social and
governance objectives. The effects of global climate change and
related natural disasters could negatively affect our business and
operations. Global economic conditions may magnify certain risks
that affect our business. 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. We
may not be able to access the capital and credit markets on terms
that are favorable to us, or at all.
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, any
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
Madison Howard,
872-202-6221(media)
Jessica Akopyan, 805-440-5721
(media)
Justin Claeys, 805-313-9775
(investors)
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SOURCE Amgen