New data for TEZSPIRE and BREZTRI
demonstrate AstraZeneca’s innovation and commitment to transform
care in COPD
AstraZeneca will showcase new clinical and real-world data
across its leading inhaled, biologic and early science respiratory
portfolio at the American Thoracic Society (ATS) International
Conference, in San Diego, CA from May 17 - 22, 2024. The company
will present 59 abstracts, including 12 late-breaking posters, with
a focus on unmet needs in chronic obstructive pulmonary disease
(COPD), severe asthma and eosinophilic granulomatosis with
polyangiitis (EGPA), as well as other chronic respiratory
diseases.
Sharon Barr, Ph.D., Executive Vice President, BioPharmaceuticals
R&D, AstraZeneca said: “Data at ATS demonstrate our progress in
advancing a new wave of innovative treatments, moving beyond
symptom control into disease modification, remission and one day,
cure. Today, COPD patients have highly limited options if their
disease is uncontrolled on inhaled medicines. We’re encouraged by
the results of the COURSE Phase IIa data exploring tezepelumab in a
broad population of COPD patients beyond those with baseline blood
eosinophils above 300 cells/μL and look forward to these data being
presented at the ATS International Conference.”
Ruud Dobber, Ph.D, Executive Vice President and President,
BioPharmaceuticals Business Unit, AstraZeneca, said: “Our broad
pipeline and portfolio of inhaled and biologic medicines are the
cornerstone of our bold ambition to transform respiratory care.
COPD remains one of the leading causes of death globally, and at
ATS we will present important real-world evidence reinforcing the
need to address cardiopulmonary risk in COPD as well as the
potential for our inhaled triple therapy BREZTRI to reduce this
risk.”
Highlights of AstraZeneca data at ATS 2024 include:
Leading transformation in COPD care by investigating novel
biologic medicines, targeting key drivers across a broad range of
patients including: TEZSPIRE® (tezepelumab) beyond severe asthma
targeting thymic stromal lymphopoietin (TSLP) and tozorakimab, to
reduce excess inflammation and epithelial remodelling in IL-33
driven disease
- COURSE Phase IIa trial: late-breaking data from a
proof-of-concept trial investigating tezepelumab in moderate to
very severe COPD patients. Importantly this trial included COPD
patients irrespective of inflammatory drivers, baseline blood
eosinophil levels, emphysema, chronic bronchitis, and smoking
status.1
- New mechanistic data from tozorakimab investigating its
ability to inhibit IL-33ox biologic effects and block the RAGE-EGFR
pathway vs. other IL-33 antibodies.2
Investigating the effect of inhaled triple therapy, BREZTRI®
(budesonide/ glycopyrrolate/ formoterol fumarate, BGF), on
cardiopulmonary outcomes and deepening insights into the connection
between COPD and cardiopulmonary risk
- ETHOS Phase III trial post-hoc analysis of cardiopulmonary
outcomes: the new analysis explores the effect of BGF across a
range of cardiopulmonary outcomes beyond traditional COPD
endpoints.3
- SKOPOS-MAZI retrospective analysis: the study will
provide new real-world evidence comparing mortality rates in
patients who start therapy with BGF single inhaler triple therapy
(SITT), versus multiple inhaler triple therapy (MITT) [open
combination triple therapies (ICS/LABA+ LAMA or LABA/LAMA + ICS)]
among patients with COPD in the US.4
- EXACOS-CV multi-country retrospective cohort study:
late-breaking real-world data across 8 countries, from over 1
million patients with COPD explores the risk of serious
cardiovascular events or death following a COPD exacerbation. These
data add to the growing body of evidence demonstrating the
importance of proactively addressing cardiopulmonary risk in COPD
patients.5
In asthma, advancing the science in asthma rescue with
AIRSUPRA® (albuterol-budesonide), a first-in-class
anti-inflammatory rescue therapy for asthma in the US6
- MANDALA Phase III post-hoc analysis: new efficacy data
for as-needed AIRSUPRA by baseline blood eosinophil count in
patients with moderate-to-severe asthma.7
- ACADIA trial design: outlining innovative approaches to
study design for the ACADIA study of AIRSUPRA in adolescents.8
Early pipeline science exploring innovative modalities
including novel inhaled medicines for moderate-severe add-on
treatment (“pre-biologics”) to reach a broader population of
patients
- Two potential first-in-class pre-biologic medicines being
explored in asthma:
- New Phase I safety and efficacy data for AZD8630/AMG 104, an
inhaled TSLP inhibitor in patients with moderate-to-severe
asthma.9
- Findings from a preclinical study of AZD4604, an inhaled, small
molecule selective JAK1 inhibitor in development for the treatment
of moderate-to-severe asthma. The data explores JAK selectivity and
implications for clinical inhibition compared to other currently
marketed JAK inhibitors.10
Additional AstraZeneca presentations of note include results
from the MANDARA Phase III trial for patients with EGPA. A
highlight of the MANDARA data is the impact of FASENRA®
(benralizumab) to reduce or completely eliminate oral
glucocorticoid use in these patients.11
Key AstraZeneca presentations during ATS 2024:
Presenting
author
Abstract title
Presentation details
TEZSPIRE (tezepelumab)
Singh D
Tezepelumab in adults with moderate to
very severe chronic obstructive pulmonary disease (COPD): efficacy
and safety from the Phase 2a COURSE study
705 Poster Session A101
Sunday, May 19 2:15 PM – 4:15 PM
Singh D
Tezepelumab in adults with moderate to
very severe chronic obstructive pulmonary disease (COPD): efficacy
and safety from the Phase 2a COURSE study
Late Breaking Mini Symposium Session B13
Ballroom 20A Monday, May 20 9:15 AM – 11:15 AM
Lugogo N
A Phase 4, single-arm, open-label study to
evaluate the effectiveness and safety of tezepelumab in patients
with severe asthma, including under-represented groups – Initial
results of the PASSAGE study
P646 Thematic Poster Session C34 Tuesday,
May 21 9:15 AM – 4:15 PM
Lugogo N
Clinical responses to tezepelumab in
patients with severe, uncontrolled asthma and history of nasal
polyps from the NAVIGATOR study
P595 Thematic Poster Session C31 Tuesday,
May 21 9:15 AM – 4:15 PM
BREZTRI AEROSPHERE
(budesonide/glycopyrrolate/formoterol fumarate)
Singh D
Effect of triple inhaled therapy with
budesonide/glycopyrrolate/formoterol fumarate on cardiopulmonary
events in chronic obstructive pulmonary disease: a post-hoc
analysis of ETHOS
913 Poster discussion A27 Sunday, May 19
9:15 AM – 11:15 AM
Marshall J
In silico lung deposition profiles of
three single-inhaler triple therapy combinations assessed with
functional respiratory imaging (FRI) at a low inspiratory flow
rate
919 Poster discussion A27 Sunday, May 19
9:15 AM – 11:15 AM
Pollack M
Association between severe cardiovascular
events and time following exacerbations of COPD: meta-analyses of
EXACOS-CV observational studies from 8 countries
P159 Thematic Poster Session A48 Sunday,
May 19 11:30 AM – 1:15 PM
Pollack M
Reduced risk of mortality for COPD
patients associated with initiation of treatment with single
inhaler (budesonide/glycopyrrolate/formoterol) versus multiple
inhaler triple therapy in the United States: the MAZI study
P626 Thematic Poster Session B52 Monday,
May 20 11:30 AM – 1:15 PM
FASENRA (benralizumab)
Jackson D
Systematic literature review of real-world
outcomes of benralizumab in eosinophilic granulomatosis with
polyangiitis
P655 Thematic Poster Session C34 Tuesday,
May 21 11:30 AM – 1:15 PM
Pitrez PM
Impact of disease, use of biologics and
clinical remission in severe asthma: insights from a multicenter
longitudinal real-life registry in Brazil
P638 Thematic Poster Session C34 Tuesday,
May 21 11:30 AM – 1:15 PM
Nair P
Effect of benralizumab versus mepolizumab
on reduction in oral glucocorticoid use in patients with
eosinophilic granulomatosis with polyangiitis: Phase 3 MANDARA
study
314 RAPiD Poster Discussion Session C102
Tuesday, May 21 2:15 PM – 4:15 PM
AIRSUPRA (albuterol/budesonide)
Papi A
Efficacy of as-needed albuterol-budesonide
by baseline blood eosinophil count in patients greater than or
equal to 18 years with moderate-to-severe asthma
P604 Thematic Poster Session C31 Tuesday,
May 21 11:30 AM – 1:15 PM
Bacharier LB
A Bayesian Dynamic Borrowing Approach to
Evaluate the Efficacy of Albuterol-Budesonide As Needed in
Adolescents with Asthma: Design of the ACADIA Study
P616 Thematic Poster Session C31 Tuesday,
May 21 11:30 AM – 1:15 PM
Asthma
Lanz M
Comparative burden of disease associated
with short-acting beta2-agonist and systemic corticosteroid
exposures in US children, adolescents, and adults with asthma
302 RAPiD Poster Discussion C102 Tuesday,
May 21 2:15 PM – 4:15 PM
Early Respiratory &
Immunology
Doffman S
Phase 1 safety and efficacy of AZD8630/AMG
104 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)
P406 Thematic Poster Session A34 Sunday,
May 19 11:30 AM – 1:15 PM
Riff C
Inhaled AZD4604: local Janus Kinase 1
inhibition without systemic activity
P297 Thematic Poster Session B71 Monday,
May 19 9:15 AM – 4:15 PM
Cohen ES
Distinct pharmacology profiles of IL-33
antibodies
P594 Thematic Poster Session B32 Monday,
May 20 9:15 AM – 4:15 PM
Ritchie AI
Structural predictors of lung function
decline in the British Early COPD Network (BEACON) cohort
Mini Symposium Session C99 Tuesday, May 21
2:15 PM – 4:15 PM
Respiratory Sustainability
Shah M
Systemic exposure bioequivalence of
budesonide/glycopyrrolate/formoterol fumarate with the potential
next generation propellant hydrofluoroolefin-1234ze versus
hydrofluoroalkane-134a in healthy adults
P628 Thematic Poster Session B52 Monday,
May 21 11:30 AM – 1:15 PM
Bell JP
EXACOS CARBON: describing the greenhouse
gas emissions of healthcare resource utilization by frequency and
severity of COPD exacerbation in England
P192 Thematic Poster Session A54 Sunday,
May 19 11:30 AM – 1:15 PM
INDICATIONS AND LIMITATIONS OF USE / ISI
AIRSUPRA® (albuterol and budesonide)
- Contraindications: Hypersensitivity to albuterol,
budesonide, or to any of the excipients
- Deterioration of Asthma: Asthma may deteriorate acutely
over a period of hours or chronically over several days or longer.
If the patient continues to experience symptoms after using
AIRSUPRA or requires more doses of AIRSUPRA than usual, it may be a
marker of destabilization of asthma and requires evaluation of the
patient and their treatment regimen
- Paradoxical Bronchospasm: AIRSUPRA can produce
paradoxical bronchospasm, which may be life threatening.
Discontinue AIRSUPRA immediately and institute alternative therapy
if paradoxical bronchospasm occurs. It should be recognized that
paradoxical bronchospasm, when associated with inhaled
formulations, frequently occurs with the first use of a new
canister
- Cardiovascular Effects: AIRSUPRA, like other drugs
containing beta2-adrenergic agonists, can produce clinically
significant cardiovascular effects in some patients, as measured by
pulse rate, blood pressure, and/or other symptoms. If such effects
occur, AIRSUPRA may need to be discontinued. In addition,
beta-agonists have been reported to produce electrocardiogram (ECG)
changes, such as flattening of the T wave, prolongation of the QTc
interval, and ST-segment depression. Therefore, AIRSUPRA, like all
sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension
- Do Not Exceed Recommended Dose: Clinically significant
cardiovascular effects and fatalities have been reported in
association with excessive use of inhaled sympathomimetic
drugs
- Hypersensitivity Reactions, Including Anaphylaxis: Can
occur after administration of albuterol sulfate and budesonide,
components of AIRSUPRA, as demonstrated by cases of anaphylaxis,
angioedema, bronchospasm, oropharyngeal edema, rash, and urticaria.
Discontinue AIRSUPRA if such reactions occur
- Risk of Sympathomimetic Amines with Certain Coexisting
Conditions: AIRSUPRA, like all therapies containing
sympathomimetic amines, should be used with caution in patients
with convulsive disorders, hyperthyroidism, or diabetes mellitus
and in patients who are unusually responsive to sympathomimetic
amines
- Hypokalemia: Beta-adrenergic agonist medicines may
produce significant hypokalemia in some patients. The decrease in
serum potassium is usually transient, not requiring
supplementation
- Immunosuppression and Risk of Infections: Due to
possible immunosuppression from the use of inhaled corticosteroids
(ICS), potential worsening of infections could occur. Use with
caution. A more serious or fatal course of chickenpox or measles
can occur in susceptible patients
- Oropharyngeal Candidiasis: Has occurred in patients
treated with ICS agents. Monitor patients periodically. Advise
patients to rinse his/her mouth with water, if available, without
swallowing after inhalation
- Hypercorticism and Adrenal Suppression: May occur with
very high doses in susceptible individuals. If such changes occur,
consider appropriate therapy
- Reduction in Bone Mineral Density: Decreases in bone
mineral density have been observed with long-term administration of
ICS. For patients at high risk for decreased bone mineral density,
assess initially and periodically thereafter
- Glaucoma and Cataracts: Have been reported following the
long-term administration of ICS, including budesonide, a component
of AIRSUPRA
- Effects on Growth: Orally inhaled corticosteroids,
including budesonide, may cause a reduction in growth velocity when
administered to pediatric patients. The safety and effectiveness of
AIRSUPRA have not been established in pediatric patients, and
AIRSUPRA is not indicated for use in this population
- Most common adverse reactions (incidence ≥ 1%) are
headache, oral candidiasis, cough, and dysphonia
- Drug Interactions: AIRSUPRA should be administered with
caution to patients being treated with:
- Strong cytochrome P450 3A4 inhibitors (may cause systemic
corticosteroid effects)
- Short-acting bronchodilators (concomitant use of additional
beta-agonists with AIRSUPRA should be used judiciously to prevent
beta-agonist overdose)
- Beta-blockers (may block pulmonary effects of beta-agonists and
produce severe bronchospasm)
- Diuretics or non-potassium-sparing diuretics (may potentiate
hypokalemia or ECG changes). Consider monitoring potassium
levels
- Digoxin (may decrease serum digoxin levels). Consider
monitoring digoxin levels
- Monoamine oxidase inhibitors (MAOI) or tricyclic
antidepressants (Use AIRSUPRA with extreme caution; may potentiate
effect of albuterol on the cardiovascular system)
- Use AIRSUPRA with caution in patients with hepatic impairment,
as budesonide systemic exposure may increase. Monitor patients with
hepatic disease
INDICATION
AIRSUPRA is a combination of albuterol, a beta2-adrenergic
agonist and budesonide, a corticosteroid, indicated for the
as-needed treatment or prevention of bronchoconstriction and to
reduce the risk of exacerbations in patients with asthma 18 years
of age and older.
Please see full Prescribing Information,
including Patient Information.
You may report side effects related to AstraZeneca products.
BREZTRI AEROSPHERE® (budesonide, glycopyrrolate, and
formoterol fumarate) Inhalation Aerosol
- BREZTRI is contraindicated in patients who have a
hypersensitivity to budesonide, glycopyrrolate, formoterol
fumarate, or product excipients
- BREZTRI is not indicated for treatment of asthma. Long-acting
beta2-adrenergic agonist (LABA) monotherapy for asthma is
associated with an increased risk of asthma-related death. These
findings are considered a class effect of LABA monotherapy. When a
LABA is used in fixed-dose combination with ICS, data from large
clinical trials do not show a significant increase in the risk of
serious asthma-related events (hospitalizations, intubations,
death) compared with ICS alone. Available data do not suggest an
increased risk of death with use of LABA in patients with COPD
- BREZTRI should not be initiated in patients with acutely
deteriorating COPD, which may be a life-threatening condition
- BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute
symptoms; treat with an inhaled short-acting beta2-agonist
- BREZTRI should not be used more often than recommended; at
higher doses than recommended; or in combination with
LABA-containing medicines, due to risk of overdose. Clinically
significant cardiovascular effects and fatalities have been
reported in association with excessive use of inhaled
sympathomimetic drugs
- Oropharyngeal candidiasis has occurred in patients treated with
orally inhaled drug products containing budesonide. Advise patients
to rinse their mouths with water without swallowing after
inhalation
- Lower respiratory tract infections, including pneumonia, have
been reported following ICS. Physicians should remain vigilant for
the possible development of pneumonia in patients with COPD as the
clinical features of pneumonia and exacerbations frequently
overlap
- Due to possible immunosuppression, potential worsening of
infections could occur. Use with caution. A more serious or fatal
course of chickenpox or measles can occur in susceptible
patients
- Particular care is needed for patients transferred from
systemic corticosteroids to ICS because deaths due to adrenal
insufficiency have occurred in patients during and after transfer.
Taper patients slowly from systemic corticosteroids if transferring
to BREZTRI
- Hypercorticism and adrenal suppression may occur with regular
or very high dosage in susceptible individuals. If such changes
occur, consider appropriate therapy
- Caution should be exercised when considering the
coadministration of BREZTRI with long-term ketoconazole and other
known strong CYP3A4 Inhibitors. Adverse effects related to
increased systemic exposure to budesonide may occur
- If paradoxical bronchospasm occurs, discontinue BREZTRI
immediately and institute alternative therapy
- Anaphylaxis and other hypersensitivity reactions (eg,
angioedema, urticaria or rash) have been reported. Discontinue and
consider alternative therapy
- Use caution in patients with cardiovascular disorders,
especially coronary insufficiency, as formoterol fumarate can
produce a clinically significant cardiovascular effect in some
patients as measured by increases in pulse rate, systolic or
diastolic blood pressure, and also cardiac arrhythmias, such as
supraventricular tachycardia and extrasystoles
- Decreases in bone mineral density have been observed with
long-term administration of ICS. Assess initially and periodically
thereafter in patients at high risk for decreased bone mineral
content
- Glaucoma and cataracts may occur with long-term use of ICS.
Worsening of narrow-angle glaucoma may occur, so use with caution.
Consider referral to an ophthalmologist in patients who develop
ocular symptoms or use BREZTRI long term. Instruct patients to
contact a healthcare provider immediately if symptoms occur
- Worsening of urinary retention may occur. Use with caution in
patients with prostatic hyperplasia or bladder-neck obstruction.
Instruct patients to contact a healthcare provider immediately if
symptoms occur
- Use caution in patients with convulsive disorders,
thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually
responsive to sympathomimetic amines
- Be alert to hypokalemia or hyperglycemia
- Most common adverse reactions in a 52-week trial (incidence ≥
2%) were upper respiratory tract infection (5.7%), pneumonia
(4.6%), back pain (3.1%), oral candidiasis (3.0%), influenza
(2.9%), muscle spasms (2.8%), urinary tract infection (2.7%), cough
(2.7%), sinusitis (2.6%), and diarrhea (2.1%). In a 24-week trial,
adverse reactions (incidence ≥ 2%) were dysphonia (3.3%) and muscle
spasms (3.3%)
- BREZTRI should be administered with extreme caution to patients
being treated with monoamine oxidase inhibitors and tricyclic
antidepressants, as these may potentiate the effect of formoterol
fumarate on the cardiovascular system
- BREZTRI should be administered with caution to patients being
treated with:
- Strong cytochrome P450 3A4 inhibitors (may cause systemic
corticosteroid effects)
- Adrenergic drugs (may potentiate effects of formoterol
fumarate)
- Xanthine derivatives, steroids, or non-potassium sparing
diuretics (may potentiate hypokalemia and/or ECG changes)
- Beta-blockers (may block bronchodilatory effects of
beta-agonists and produce severe bronchospasm)
- Anticholinergic-containing drugs (may interact additively).
Avoid use with BREZTRI
- Use BREZTRI with caution in patients with hepatic impairment,
as budesonide and formoterol fumarate systemic exposure may
increase. Patients with severe hepatic disease should be closely
monitored
INDICATION
BREZTRI AEROSPHERE is indicated for the maintenance treatment of
patients with chronic obstructive pulmonary disease (COPD).
LIMITATIONS OF USE
Not indicated for the relief of acute bronchospasm or for the
treatment of asthma.
Please see full BREZTRI Prescribing Information,
including Patient Information.
You may report side effects related to AstraZeneca products.
FASENRA ® (benralizumab)
CONTRAINDICATIONS
Known hypersensitivity to benralizumab or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g., anaphylaxis, angioedema,
urticaria, rash) have occurred after administration of FASENRA.
These reactions generally occur within hours of administration, but
in some instances have a delayed onset (i.e., days). Discontinue in
the event of a hypersensitivity reaction.
Acute Asthma Symptoms or Deteriorating Disease
FASENRA should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly
upon initiation of therapy with FASENRA. 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 FASENRA will influence a patient’s response
against helminth infections. Treat patients with pre-existing
helminth infections before initiating therapy with FASENRA. If
patients become infected while receiving FASENRA and do not respond
to anti-helminth treatment, discontinue FASENRA until infection
resolves.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5%) include
headache and pharyngitis.
Injection site reactions (e.g., pain, erythema, pruritus,
papule) occurred at a rate of 2.2% in patients treated with FASENRA
compared with 1.9% in patients treated with placebo.
USE IN SPECIFIC POPULATIONS
A pregnancy exposure registry monitors pregnancy outcomes in
women exposed to FASENRA during pregnancy. To enroll call
1-877-311-8972 or visit www.mothertobaby.org/Fasenra.
The data on pregnancy exposure from the clinical trials are
insufficient to inform on drug-associated risk. Monoclonal
antibodies such as benralizumab are transported across the placenta
during the third trimester of pregnancy; therefore, potential
effects on a fetus are likely to be greater during the third
trimester of pregnancy.
INDICATION
FASENRA is indicated for the add-on maintenance treatment of
patients with severe asthma aged 6 years and older, and with an
eosinophilic phenotype.
- FASENRA is not indicated for treatment of other eosinophilic
conditions
- FASENRA is not indicated for the relief of acute bronchospasm
or status asthmaticus
Please read full Prescribing Information,
including Patient Information and Instructions
for Use.
You may report side effects related to AstraZeneca products.
TEZSPIRE® (tezepelumab)
CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials
(eg, 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 (ie, 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.
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.
Please see full Prescribing Information,
including Patient Information and Instructions
for Use.
You may report side effects related to AstraZeneca products.
Notes
Data presented does not reflect any head-to-head
comparisons.
Chronic Obstructive Pulmonary Disease (COPD)
COPD refers to a group of lung diseases, including chronic
bronchitis and emphysema, that cause airflow blockage and
breathing-related problems.12 COPD is the third leading cause of
death due to chronic disease and the sixth leading cause of
mortality in the United States. COPD accounts for the majority of
chronic lower respiratory mortality in the US at 150,000 deaths per
year, and data suggests patients with COPD are, on average, 50
times more likely to die from their condition compared to those
with asthma. 13,14
The lungs and heart are fundamentally linked and work
together.15 COPD mechanisms elevate the risk of both lung and heart
events, including severe or even fatal COPD exacerbations and
cardiac events, known as cardiopulmonary risk.16-19 Approximately 1
in 5 patients with COPD will die within a year of their first
hospitalisation for an exacerbation, and pulmonary and cardiac
events are a key driver of mortality and the most common reasons
for death in patients with COPD.16,20-22
Severe asthma
Severe asthma is an often-debilitating, potentially fatal
condition affecting up to 26 million people worldwide.23-26
Patients may be uncontrolled despite high dosages of standard of
care asthma controller medicines, experiencing frequent
exacerbations and significant limitations on lung function and
health-related quality of life as a result.23,25-27
Eosinophilic granulomatosis with polyangiitis (EGPA)
EGPA, formerly known as Churg-Strauss Syndrome, is a rare,
immune-mediated inflammatory disease that is caused by inflammation
of small to medium-sized blood vessels.28,29 It is estimated that
118,000 people throughout the world live with EGPA.30
EGPA can result in damage to multiple organs, including lungs,
upper airway, skin, heart, gastrointestinal tract and nerves.28 The
most common symptoms and signs include extreme fatigue, weight
loss, muscle and joint pain, rashes, nerve pain, sinus and nasal
symptoms, and shortness of breath. Without treatment, the disease
may be fatal.28,31 Almost half (47%) of patients do not achieve
remission with current treatments.28,32
AIRSUPRA
AIRSUPRA (albuterol/budesonide), formerly known as PT027, is a
first-in-class SABA/ICS rescue treatment for asthma in the US, to
be taken as needed. It is an inhaled, fixed-dose combination rescue
medication containing albuterol (also known as salbutamol), a SABA,
and budesonide, a corticosteroid, and has been developed in a pMDI
using AstraZeneca’s Aerosphere delivery technology.33
The FDA approval of AIRSUPRA was based on MANDALA and DENALI
Phase III trials (Approval press release). In MANDALA, AIRSUPRA
significantly reduced the risk of severe exacerbations compared to
albuterol in patients with moderate-to-severe asthma when used as
an as-needed rescue medication in response to symptoms. For
patients treated with AIRSUPRA 180 mcg/160 mcg the annualized total
systemic corticosteroids dose when compared with albuterol 180 mcg
was statistically significantly different, with a reduction in mean
annualized dose of 40 mg per patient. In DENALI, AIRSUPRA
significantly improved lung function compared to the individual
components albuterol and budesonide in patients with mild to
moderate asthma.
BREZTRI
BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol
fumarate) is a single-inhaler, fixed-dose triple-combination of
formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with
budesonide, an ICS, and delivered via the AEROSPHERE pressurised
metered-dose inhaler. BREZTRI AEROSPHERE is approved to treat COPD
in more than 50 countries worldwide including the US, EU, China and
Japan, and is currently being studied in Phase III trials for
asthma.
FASENRA
FASENRA is a monoclonal antibody that binds directly to IL-5
receptor alpha on eosinophils and attracts natural killer cells to
induce rapid and near-complete depletion of blood and tissue
eosinophils in most patients via apoptosis (programmed cell
death).34,35
FASENRA (benralizumab) is currently approved in more than 80
countries, including the US, EU, and Japan, and is approved for
self-administration in the US, EU and other countries.36-38 FASENRA
has been prescribed to over 100,000 patients in the US.39
FASENRA is in development for other diseases including chronic
obstructive pulmonary disease, chronic rhinosinusitis with nasal
polyps and hypereosinophilic syndrome.40-42
FASENRA was developed by AstraZeneca and is in-licensed from
BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd.,
Japan.
TEZSPIRE
TEZSPIRE (tezepelumab) is being developed by AstraZeneca in
collaboration with Amgen as a first-in-class human monoclonal
antibody that inhibits the action of TSLP, a key epithelial
cytokine that sits at the top of multiple inflammatory cascades and
is critical in the initiation and persistence of allergic,
eosinophilic and other types of airway inflammation associated with
severe asthma, including airway hyperresponsiveness.44,45 TEZSPIRE
is approved in the US, EU, Japan and other countries for the
treatment of severe asthma.46-48
Amgen collaboration
In 2020, Amgen and AstraZeneca updated a 2012 collaboration
agreement for TEZSPIRE. Both companies will continue to share costs
and profits equally after payment by AstraZeneca of a mid
single-digit inventor 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 US, with AZ recording its
share of US profits as Collaboration Revenue. Outside of the US,
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 AMG 104 / 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 AMG 104 / AZD8630 in North America, and
AstraZeneca will distribute the product and book sales globally,
including for the US.
Respiratory & Immunology
Respiratory & Immunology, part of BioPharmaceuticals, is one
of AstraZeneca’s main disease areas and is a key growth driver for
the Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage. The Company aims to transform the treatment of
asthma and COPD by focusing on earlier biology-led treatment,
eliminating preventable asthma attacks, and removing COPD as a
top-three leading cause of death. The Company’s early respiratory
research is focused on emerging science involving immune
mechanisms, lung damage and abnormal cell-repair processes in
disease and neuronal dysfunction.
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas. The
Company’s growing presence in immunology is focused on five mid- to
late-stage franchises with multi-disease potential, in areas
including rheumatology (including systemic lupus erythematosus),
dermatology, gastroenterology, and systemic eosinophilic-driven
diseases. AstraZeneca’s ambition in Respiratory & Immunology is
to achieve disease modification and durable remission for millions
of patients worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines in Oncology, Rare Diseases and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 100 countries, and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
social media @AstraZeneca.
References
- Singh D, Bafadhel M, Brightling C, et al. Tezepelumab in adults
with moderate to very severe chronic obstructive pulmonary disease
(COPD): efficacy and safety from the Phase 2a COURSE study. [Late
breaking Mini Symposium Session]. Presented at the American
Thoracic Society International Conference 2024 (17-22 May).
- Cohen ES, Strickson S, Scott IC, et al. Distinct pharmacology
profiles of IL-33 antibodies. [Thematic Poster Session]. Presented
at the American Thoracic Society International Conference 2024
(17-22 May).
- Singh D, Martinez FJ, Hurst JR, et al. Effect of triple inhaled
therapy with budesonide/glycopyrrolate/formoterol fumarate on
cardiopulmonary events in chronic obstructive pulmonary disease: a
post-hoc analysis of ETHOS. [Poster Discussion]. Presented at the
American Thoracic Society International Conference 2024 (17-22
May).
- Pollack M, Rapsomaniki E, Anzueto A, et al. Increased risk of
mortality for COPD patients associated with initiation of treatment
with multiple inhaler triple therapy initiation versus single
inhaler (budesonide/glycopyrrolate/formoterol) in the United
States: the MAZI study. [Thematic Poster Session]. Presented at the
American Thoracic Society International Conference 2024 (17-22
May).
- Pollack M, Nordon C, Rhodes K, et al. Association between
severe cardiovascular events and time following exacerbations of
COPD: meta-analyses of EXACOS-CV observational studies from 8
countries. [Thematic Poster Session]. Presented at the American
Thoracic Society International Conference 2024 (17-22 May).
- AstraZeneca. AIRSUPRA® (PT027) approved in the US for asthma.
Available at:
https://www.astrazeneca-us.com/media/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html.
[Last accessed: April 2024].
- Papi A, Chipps B, Beasley R, et al. Efficacy of as-needed
albuterol-budesonide by baseline blood eosinophil count in patients
greater than or equal to 18 years with moderate-to-severe asthma.
[Thematic Poster Session]. Presented at the American Thoracic
Society International Conference 2024 (17-22 May).
- Bacharier LB, Bardsley S, Dunsire L, et al. A Bayesian Dynamic
Borrowing Approach to Evaluate the Efficacy of Albuterol-Budesonide
As Needed in Adolescents with Asthma: Design of the ACADIA Study.
[Thematic Poster Session]. Presented at the American Thoracic
Society International Conference 2024 (17-22 May).
- Doffman S, Dosanjh D, Sadiq MW. Phase 1 safety and efficacy of
AZD8630/AMG 104 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].
Presented at the American Thoracic Society International Conference
2024 (17-22 May).
- Riff C, Larsson J, Nilsson M, et al. Inhaled AZD4604: local
Janus Kinase 1 inhibition without systemic activity. [Thematic
Poster Session]. Presented at the American Thoracic Society
International Conference 2024 (17-22 May).
- Nair P, Wechsler M, Bourdin A, et al. Effect of benralizumab
versus mepolizumab on reduction in oral glucocorticoid use in
patients with eosinophilic granulomatosis with polyangiitis: Phase
3 MANDARA study. [RAPiD Poster Discussion Session]. Presented at
the American Thoracic Society International Conference 2024 (17-22
May).
- GOLD. Global Strategy for the Diagnosis, Management and
Prevention of COPD, Global Initiative for Chronic Obstructive Lung
Disease (GOLD), 2023. [Online]. Available at: http://goldcopd.org.
[Last accessed: April 2024].
- Centers for Disease Control and Prevention (CDC). Leading
Causes of Death. United States: CDC; January 17, 2024,
https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm.
Accessed April 11, 2024.
- National Heart, Lung, and Blood Institute (NIH). Learn More
Breathe Better: United States: NIH.
https://www.nhlbi.nih.gov/BreatheBetter. Accessed April 11,
2024.
- American Lung Association. Your Heart and Lungs: The Ultimate
Relationship (2023) Available at:
https://www.lung.org/blog/heart-lung-relationship. [Last accessed:
April 2024].
- Ho TW, Tsai YJ, Ruan SY, et al. In-Hospital and One-Year
Mortality and Their Predictors in Patients Hospitalized for
First-Ever Chronic Obstructive Pulmonary Disease Exacerbations: A
Nationwide Population-Based Study. PLOS ONE. 2014; 9 (12):
e114866.
- Donaldson GC et al. Increased risk of myocardial infarction and
stroke following exacerbation of COPD. Chest.
2010;137:1091-1097;9-2029.
- Watz H et al. Spirometric changes during exacerbations of COPD:
A post hoc analysis of the WISDOM trial. Respir Res.
2018;19(1):251.
- Suissa S et al. Long-term natural history of chronic
obstructive pulmonary disease: severe exacerbations and mortality.
Thorax. 2012;67(11):957-963.
- Lindenauer PK, Dharmarajan K, Qin L, et al. Risk Trajectories
of Readmission and Death in the First Year After Hospitalization
for Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care
Med. 2018 Apr 15;197(8):1009-1017.
- García-Sanz MT, Cánive-Gómez JC, Senín-Rial L, et al. One-year
and long-term mortality in patients hospitalized for chronic
obstructive pulmonary disease. J Thorac Dis. 2017; 9 (3): 636‐645.
doi:10.21037/jtd.2017.03.34.
- Mannino DM et al. Global Initiative on Obstructive Lung Disease
(GOLD) classification of lung disease and mortality: findings from
the Atherosclerosis Risk in Communities (ARIC) study. Respir Med.
2006;100: pp.115-122.
- Chung, KF, et al. International ERS/ATS guidelines on
definition, evaluation and treatment of severe asthma. Eur Respir
J. 2014 Feb;43(2):343-73.
- The Global Asthma Network. The Global Asthma Report 2022.
Available at:
http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf.
[Last accessed: April 2024].
- Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med.
2005;172:149-60.
- Fernandes AG, et al. Risk factors for death in patients with
severe asthma. J Bras Pneumol. 2014; 40: 364-372.
- Peters SP, et al. Uncontrolled asthma: a review of the
prevalence, disease burden and options for treatment. Respir Med
2006;100(7):1139-51.
- American Partnership for Eosinophilic Disorders. Eosinophilic
Granulomatosis with Polyangiitis (EGPA). Available at:
https://apfed.org/about-ead/eosinophilic-granulomatosis-with-polyangiitis/.
[Last accessed: April 2024].
- Furuta S, Iwamoto T, Nakajima H. Update on eosinophilic
granulomatosis with polyangiitis. Allergol Int.
2019;68:430-436.
- AstraZeneca Data on file. 2022. REF-167820.
- Baldini C, et al. Clinical Manifestations and Treatment of
Churg-Strauss Syndrome. Rheum Dis Clin N Am. 2010;36:527–543.
- Cottin V, et al. Respiratory manifestations of eosinophilic
granulomatosis with polyangiitis (Churg–Strauss). Eur Respir J.
2016;48:1429-1441.
- Airsupra (albuterol/budesonide) US prescribing information;
2022.
- Kolbeck R, et al. MEDI-563, a humanized anti-IL-5 receptor a
mAb with enhanced antibody-dependent cell-mediated cytotoxicity
function. J Allergy Clin Immunol. 2010;125:1344-1353.e2.
- Pham TH, et al. Reductions in eosinophil biomarkers by
benralizumab in patients with asthma. Respir Med.
2016;111:21-29.
- AstraZeneca news release. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-approved-in-the-us-for-self-administration-in-a-new-pre-filled-auto-injector-the-fasenra-pen-04102019.html.
[Last accessed: April 2024].
- AstraZeneca news release. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-receives-positive-eu-chmp-opinion-for-self-administration-and-the-new-fasenra-pen-a-pre-filled-single-use-auto-injector-01072019.html.
[Last accessed: April 2024].
- AstraZeneca Annual Report 2023. Available at:
https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf.
[Last accessed: April 2024].
- AstraZeneca plc. FY and Q4 2023 Results. Conference call and
webcast for investors and analysts. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2024/full-year-and-q4-2023-results.html.
[Last accessed April 2024].
- Clinicaltrials.gov. Efficacy and Safety of Benralizumab in
Moderate to Very Severe Chronic Obstructive Pulmonary Disease
(COPD) With a History of Frequent Exacerbations (RESOLUTE).
Available from: https://clinicaltrials.gov/ct2/show/NCT04053634.
[Last accessed: April 2024].
- Clinicaltrials.gov. Efficacy and Safety Study of Benralizumab
in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal
Polyps (ORCHID). Available at:
https://clinicaltrials.gov/ct2/show/NCT04157335. [Last accessed:
April 2024].
- Clinicaltrials.gov. A Phase 3 Study to Evaluate the Efficacy
and Safety of Benralizumab in Patients With Hypereosinophilic
Syndrome (HES) (NATRON). Available from:
https://clinicaltrials.gov/ct2/show/NCT04191304. [Last Accessed:
April 2024].
- Airsupra (albuterol/budesonide) US prescribing information;
2022.
- Corren J, et al. Tezepelumab in adults with uncontrolled asthma
[supplementary appendix; updated April 18, 2019]. N Engl J Med.
2017;377:936-946.
- Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms,
Inflammatory Disorders, and Cancer. Front Immunol.
2018;9:1595.
- AstraZeneca plc. Tezspire (tezepelumab) approved in the US for
severe asthma. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2021/tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html.
[Last accessed: April 2024].
- AstraZeneca plc. Tezspire approved in the EU for the treatment
of severe asthma. 2022. Available at:
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html.
[Last accessed: April 2024].
- AstraZeneca plc. Tezspire approved in Japan for the treatment
of severe asthma. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html.
[Last accessed: April 2024].
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