Findings From Tezspire®
(tezepelumab-ekko) Phase 2a COURSE COPD Study
Phase 1 Study on AMG104/AZD8630 (Inhaled
Anti-TSLP) in Moderate to Severe Asthma
New TAVNEOS® (avacopan) Data
in Adults With Severe Active ANCA-Associated Vasculitis With Lung
Involvement
THOUSAND
OAKS, Calif., May 1, 2024
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the
presentation of new respiratory data at the American Thoracic
Society (ATS) 2024 International Conference taking place
May 12-22 in San Diego. Thirteen abstracts supporting two
approved medicines and one investigational treatment will be
presented.
"We look forward to presenting encouraging data from our Phase
2a COURSE trial in COPD with Tezspire and our Phase 1
investigational study of asthma with AMG104/AZD8630, an inhaled
anti-TSLP therapy," said Jay
Bradner, M.D., executive vice president of Research and
Development and chief scientific officer at Amgen. "Our efforts
underscore Amgen's commitment to pioneering new treatments for
respiratory diseases with currently limited treatment options."
Data from the COURSE trial will be presented within the Clinical
Trials Symposium. COURSE was a proof-of-concept, Phase 2a study
evaluating the safety and efficacy of Tezspire®
(tezepelumab-ekko) in patients with moderate to very severe chronic
obstructive pulmonary disease (COPD), irrespective of inflammatory
drivers, blood eosinophil count (BEC), emphysema, chronic
bronchitis and smoking status.
Other research highlights include late-breaking data from the
Phase 1 study of AMG104/AZD8630, an investigational inhaled
anti-TSLP therapy being evaluated in patients with poorly
controlled asthma, as well as a post-hoc analysis from the Phase 3
ADVOCATE trial, which assessed the efficacy and safety of
TAVNEOS® (avacopan) in patients with severe active
ANCA-associated vasculitis (GPA or MPA) with lung
involvement.
Abstracts and Presentation Times:
TEZSPIRE
- Tezepelumab in Adults with Moderate to Very Severe Chronic
Obstructive Pulmonary Disease (COPD): Efficacy and Safety from the
Phase 2a COURSE Study
Scientific Symposium Session B13,
May 20, 9:50
a.m. – 10:05 a.m. PDT
- Tezepelumab in Adults with Moderate to Very Severe Chronic
Obstructive Pulmonary Disease (COPD): Efficacy and Safety from the
Phase 2a COURSE Study
Poster Discussion Session A101, Room
30C-E, May 19, 2:15 p.m. – 4:15 p.m.
PDT
- Clinical Responses to Tezepelumab in Patients with Severe,
Uncontrolled Asthma and a History of Nasal Polyps from the
NAVIGATOR Study
Thematic Poster Session C31, Hall A-B2,
May 21, 11:30
a.m. – 1:15 p.m. PDT
- A Phase 4, Single-Arm, Open-Label Study to Evaluate the
Effectiveness and Safety of Tezepelumab in Patients with Severe
Asthma, Including Underrepresented Racial and Clinical Groups:
Initial Baseline Demographics and Clinical Characteristics from the
PASSAGE Study
Thematic Poster Session C34, Hall A-B2,
May 21, 11:30
a.m. – 1:15 p.m. PDT
- Effect of Biologics on Biomarkers of Type 2 Inflammation in
Asthma: A Review of the Literature
Thematic Poster Session
C34, Hall A-B2, May 21, 11:30 a.m. – 1:15 p.m.
PDT
- Efficacy of Biologics for Reducing Exacerbations Requiring
Hospitalization or an Emergency Department Visit in Patients with
Moderate to Severe, Uncontrolled Asthma
Thematic Poster
Session C34, Hall A-B2, May 21,
11:30 a.m. – 1:15 p.m. PDT
- Efficacy of Tezepelumab in Black or African American
Patients: A Pooled Analysis of the PATHWAY and NAVIGATOR
Studies
Thematic Poster Session C34, Hall A-B2, May 21, 11:30 a.m.
– 1:15 p.m. PDT
- Effect of Tezepelumab on Exercise Tolerance in Patients with
Severe, Uncontrolled Asthma from the NAVIGATOR
Study
Thematic Poster Session C34, Hall A-B2, May 21, 11:30 a.m.
– 1:15 p.m. PDT
- Patient Characteristics and Treatment Patterns with
Tezepelumab in the United States:
An Early Claims Data Study
Thematic Poster Session A35, Hall
A-B2, May 21, 11:30 a.m. – 1:15 p.m.
PDT
- Asthma Exacerbation Rates as a Function of Biomarker Levels
4 Weeks After Initiation of Tezepelumab Treatment: An Analysis of
the NAVIGATOR Study
RAPiD Poster Discussion Session C102,
Room 28C-E, May 21, 2:15 p.m. – 4:15 p.m.
PDT
- Reduced Mucus Plugging with Tezepelumab is Spatially
Associated with Reduced Air Trapping in a Broad Population of
Patients with Moderate to Severe Asthma
RAPiD Poster Discussion Session C102, Room 28C-E, May 21, 2:15 p.m. –
4:15 p.m. PDT
SEVERE ASTHMA DISEASE BURDEN
- Greater Exacerbation Reductions with Earlier Biologic
Initiation After Severe Asthma Onset: Results from the CHRONICLE
Study
RAPiD Poster Discussion Session C102, Room 28C-E,
May 19, 2:15
p.m. – 4:15 p.m. PDT
AMG104/AZD8630 (iTSLP)
- Phase 1 Safety and Efficacy of AZD8630/AMG104 Inhaled
Anti-TSLP in Healthy Volunteers and Patients with Asthma on
Medium-High Dose Inhaled Corticosteroid (ICS) and Long-Acting
Beta-Agonist (LABA) with Elevated Baseline Fractional Exhaled
Nitric Oxide (FeNO)
Thematic Poster Session A34, Hall
A-B2, May 19, 2:15 p.m. – 4:15 p.m.
PDT
TAVNEOS
- Efficacy and Safety of Avacopan Versus Prednisone Taper
in Patients with ANCA-Associated Vasculitis with Lung Involvement:
A Post Hoc Analysis of the ADVOCATE Trial
Poster Discussion
Session A26, Room 30C-E, May 19,
9:15 a.m. – 11:15 a.m. PDT
About
TEZSPIRE® (tezepelumab-ekko)
TEZSPIRE is a
first-in-class human monoclonal antibody that works on the primary
source of inflammation: the airway epithelium, which is the first
point of contact for viruses, allergens, pollutants and other
environmental insults. Specifically, TEZSPIRE targets and blocks
thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that
sits at the top of multiple inflammatory cascades and initiates an
overreactive immune response to allergic, eosinophilic and other
types of airway inflammation associated with severe
asthma.1,2 TSLP is released in response to
multiple triggers associated with asthma exacerbations, including
allergens, viruses and other airborne particles.1,2
Expression of TSLP is increased in the airways of patients with
asthma and has been correlated with disease severity.1,3
Blocking TSLP may prevent the release of pro-inflammatory cytokines
by immune cells, resulting in the prevention of asthma
exacerbations and improved asthma control.1,3 By working
at the top of the cascade, TEZSPIRE helps stop inflammation at the
source and has the potential to treat a broad population of severe
asthma patients.1,3
TEZSPIRE is also in development for other potential indications
including chronic obstructive pulmonary disease, chronic
rhinosinusitis with nasal polyps, chronic spontaneous urticaria and
eosinophilic esophagitis (EoE). In October 2021, tezepelumab
was granted Orphan Drug Designation by the FDA for the treatment of
EoE.
About the Amgen and AstraZeneca
Collaboration
In 2020, Amgen and AstraZeneca
updated the 2012 collaboration agreement for TEZSPIRE. Both
companies will continue to share costs and profits equally after
payment by AstraZeneca of a mid-single-digit royalty to Amgen.
AstraZeneca continues to lead development
and Amgen continues to lead manufacturing. All aspects of
the collaboration are under the oversight of joint governing
bodies. Under the amended agreement, Amgen and
AstraZeneca will jointly commercialize TEZSPIRE in North
America. Amgen will record product sales in
the U.S., with AstraZeneca recording its share
of U.S. profits as Collaboration Revenue. Outside of
the U.S., AstraZeneca will record product sales,
with Amgen recording profit share as Other/Collaboration
revenue.
In addition, we are also collaborating with AstraZeneca on
AMG104/AZD8630, an inhaled anti-TSLP compound currently in
development for asthma. In November
2021, Amgen and AstraZeneca agreed to include AMG104/AZD8630
in the existing collaboration agreement. The companies share both
costs and income, with no inventor royalty. AstraZeneca will be the
development, manufacturing and commercial lead. AstraZeneca and
Amgen will jointly commercialize AMG104/AZD8630 in North America, and AstraZeneca will distribute
the product and book sales globally, including for the
U.S.
TEZSPIRE® (tezepelumab-ekko) U.S. Indication
TEZSPIRE is indicated for the add-on maintenance treatment of
adult and pediatric patients aged 12 years and older with severe
asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm
or status asthmaticus.
TEZSPIRE® (tezepelumab-ekko) Important Safety
Information
CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials
(e.g., rash and allergic conjunctivitis) following the
administration of TEZSPIRE. Postmarketing cases of anaphylaxis have
been reported. These reactions can occur within hours of
administration, but in some instances have a delayed onset (i.e.,
days). In the event of a hypersensitivity reaction, consider the
benefits and risks for the individual patient to determine whether
to continue or discontinue treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms,
acute exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly
upon initiation of therapy with TEZSPIRE. Reductions in
corticosteroid dose, if appropriate, should be gradual and
performed under the direct supervision of a physician. Reduction in
corticosteroid dose may be associated with systemic withdrawal
symptoms and/or unmask conditions previously suppressed by systemic
corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient's response
against helminth infections. Treat patients with pre-existing
helminth infections before initiating therapy with TEZSPIRE. If
patients become infected while receiving TEZSPIRE and do not
respond to anti-helminth treatment, discontinue TEZSPIRE until
infection resolves.
Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has
not been evaluated. The use of live attenuated vaccines should be
avoided in patients receiving TEZSPIRE.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3%) are
pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to
evaluate for any drug-associated risk of major birth defects,
miscarriage, or other adverse maternal or fetal outcomes. Placental
transfer of monoclonal antibodies such
as tezepelumab-ekko is greater during the third trimester
of pregnancy; therefore, potential effects on a fetus are likely to
be greater during the third trimester of pregnancy.
Please see the full Prescribing
Information including Patient
Information and Instructions for
Use.
You may report side effects related to AstraZeneca products
by clicking here.
About TAVNEOS® (avacopan)
TAVNEOS
(avacopan), approved by the FDA as an adjunctive treatment of
ANCA-associated vasculitis, is a first-in-class, orally
administered small molecule that employs a novel, highly targeted
mode of action in complement-driven autoimmune and inflammatory
diseases. While the precise mechanism in ANCA vasculitis 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
the driver of ANCA vasculitis. TAVNEOS's selective inhibition of
only the C5aR leaves the beneficial C5a pathway through the C5L2
receptor functioning normally.
TAVNEOS® (avacopan)
U.S. Indication
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® (avacopan) Important Safety
Information
CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the
excipients
WARNINGS 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 Amgen
Amgen discovers, develops, manufactures and delivers innovative
medicines to help millions of patients in their fight against some
of the world's toughest diseases. More than 40 years ago, Amgen
helped to establish the biotechnology industry and remains on the
cutting-edge of innovation, using technology and human genetic data
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deep pipeline that builds on its existing portfolio of medicines to
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and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative
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is one of the 30 companies that comprise the Dow Jones Industrial
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CONTACT: Amgen, Thousand
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References:
- Menzies-Gow A, et al. Tezepelumab in Adults
and Adolescents with Severe, Uncontrolled Asthma. N Engl J
Med. 2021;384:1800-1809. DOI: 10.1056/NEJMoa2034975.
- Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms,
Inflammatory Disorders, and Cancer. Front
Immunol. 2018; 9: 1595.
- Li Y, et al. Elevated Expression of IL-33 and TSLP in the
Airways of Human Asthmatics In Vivo: A Potential Biomarker of
Severe Refractory Disease. J Immunol. 2018; 200:
2253–2262.
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