New Biologic Therapy Available for Broad
Population of Severe Asthma Patients Without Phenotype or Biomarker
Limitations
AstraZeneca and Amgen today announced TEZSPIRE™
(tezepelumab-ekko) is now available for shipment to wholesalers in
the US. TEZSPIRE was approved by the US Food and Drug
Administration (FDA) on December 17, 2021 for the add-on
maintenance treatment of adult and pediatric patients aged 12 years
and older with severe asthma.1
Mina Makar, Senior Vice President, US Respiratory &
Immunology, AstraZeneca, said: “Due to the complexity of severe
asthma, many patients living with the disease continue to
experience frequent exacerbations, an increased risk of
hospitalization and a reduced quality of life. With TEZSPIRE now
available, this important new treatment has the potential to
transform care for a broad population of patients living with
severe asthma.”
TEZSPIRE is a first-in-class biologic for severe asthma that
acts at the top of the inflammatory cascade by targeting thymic
stromal lymphopoietin (TSLP), an epithelial cytokine.2 TEZSPIRE is
the first and only biologic approved for severe asthma with no
phenotype (e.g. eosinophilic or allergic) or biomarker limitation
within its approved label.1,3-8 TEZSPIRE consistently and
significantly reduced asthma exacerbations across Phase II and III
clinical trials which included a broad population of severe asthma
patients irrespective of key biomarkers, including blood eosinophil
counts, allergic status and fractional exhaled nitric oxide
(FeNO).2,9
In clinical studies, the most common adverse reactions in
patients who received TEZSPIRE were pharyngitis, arthralgia and
back pain.1
AstraZeneca and Amgen are committed to providing appropriate
patients who are prescribed TEZSPIRE with affordable access to the
medicine. The Tezspire Together Program offers provider and patient
product resources and support, including information related to
coverage, reimbursement and distribution. For more information
about the Tezspire Together Program, call 1-888-TZSPIRE
(1-888-897-7473) or visit Tezspire.com.
AstraZeneca and Amgen also provide patient assistance for
TEZSPIRE for qualifying individuals with no or limited drug
coverage by providing free medicines through the Tezspire Patient
Assistance Program. For additional information, patients and
caregivers may contact Tezspire Together.
TEZSPIRE™ (tezepelumab-ekko) US 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 (e.g., rash and allergic
conjunctivitis) can occur following administration of TEZSPIRE.
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, initiate appropriate treatment as
clinically indicated and then 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 TEZSPIRE full Prescribing Information.
You may report side effects related to AstraZeneca products
by clicking here.
Notes
Severe asthma
Asthma is a heterogeneous disease affecting an estimated 339
million people worldwide.10 Approximately 10% of asthma patients
have severe asthma.11,12 Despite the use of inhaled asthma
controller medicine, currently available biologic therapies and
oral corticosteroids (OCS), many severe asthma patients remain
uncontrolled.11-13 Due to the complexity of severe asthma, many
patients have unclear or multiple drivers of inflammation and may
not qualify for or respond well to a current biologic
medicine.12-15
Severe, uncontrolled asthma is debilitating with patients
experiencing frequent exacerbations, significant limitations on
lung function and a reduced quality of life.11,12 Patients with
severe asthma are at an increased risk of mortality and compared to
patients with persistent asthma have twice the risk of
asthma-related hospitalizations.16-19 There is also a significant
socio-economic burden, with these patients accounting for
approximately 50% of asthma-related costs.20
Clinical trials
In addition to the Phase IIb PATHWAY trial, the PATHFINDER
program included two Phase III trials, NAVIGATOR9,21 and
SOURCE.22,23 The program also includes additional mechanistic and
long-term safety trials.24,25
NAVIGATOR is a Phase III, randomized, double-blinded,
placebo-controlled trial in adults (18–80 years old) and
adolescents (12–17 years old) with severe, uncontrolled asthma, who
were receiving standard of care (SoC). SoC was treatment with
medium- or high-dose inhaled corticosteroids plus at least one
additional controller medication with or without daily OCS
treatment. The trial population included approximately equal
proportions of patients with high (≥300 cells per microliter) and
low (<300 cells per microliter) blood eosinophil counts. The
trial comprised a five-to-six-week screening period, a 52-week
treatment period and a 12-week post-treatment follow-up period. All
patients received their prescribed controller medications without
change throughout the trial.9
The primary efficacy endpoint was the annualized asthma
exacerbation rate (AAER) during the 52-week treatment period. Key
secondary endpoints included the effect of TEZSPIRE on lung
function, asthma control and health-related quality of life.9
As part of prespecified analyses, the AAER over 52 weeks was
also assessed in patients grouped by baseline blood eosinophil
count, FeNO level and serum specific immunoglobin E (IgE) status
(perennial aeroallergen sensitivity positive or negative).9 These
are inflammatory biomarkers used by clinicians to inform treatment
options and involve tests analyzing a patient’s blood
(eosinophils/IgE) and exhaled air (FeNO).
There were no clinically meaningful differences in safety
results between the TEZSPIRE and placebo groups in the NAVIGATOR
trial.9 The most frequently reported adverse events for TEZSPIRE
were nasopharyngitis, upper respiratory tract infection and
headache.9
NAVIGATOR is the first Phase III trial to show benefit in severe
asthma irrespective of eosinophils by targeting TSLP.9 These
results support the FDA Breakthrough Therapy Designation granted to
TEZSPIRE in September 2018 for patients with severe asthma, without
an eosinophilic phenotype. In July 2021, TEZSPIRE was the first and
only biologic to be granted Priority Review in the US for the
treatment of asthma by the FDA.
Patients who participated in our Phase III trials were eligible
to continue in DESTINATION, a Phase III extension trial assessing
long-term safety and efficacy.24
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.2,26 TSLP is
released in response to multiple triggers associated with asthma
exacerbations, including allergens, viruses and other airborne
particles.2,26 Expression of TSLP is increased in the airways of
patients with asthma and has been correlated with disease
severity.2,27 Blocking TSLP may prevent the release of
pro-inflammatory cytokines by immune cells, resulting in the
prevention of asthma exacerbations and improved asthma
control.1,2,9,27 TEZSPIRE acts at the top of the inflammation
cascade and has the potential to help address a broad population of
severe asthma patients irrespective of biomarker levels.2,9
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.
Amgen collaboration
In 2020, AstraZeneca and Amgen 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, AstraZeneca and
Amgen 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.
AstraZeneca in 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 chronic obstructive pulmonary disease (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
Twitter @AstraZenecaUS.
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- Peters SP, et al. Uncontrolled asthma: a review of the
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- Hyland ME, et al. A Possible Explanation for Non-responders,
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- Tran TN, et al. Overlap of atopic, eosinophilic, and TH2-high
asthma phenotypes in a general population with current asthma. Ann
Allergy Asthma Immunol. 2016; 116: 37–42.
- Fernandes AG, et al. Risk factors for death in patients with
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- Chastek B, et al. Economic Burden of Illness Among Patients
with Severe Asthma in a Managed Care Setting. J Manag Care Spec
Pharm. 2016;22: 848–861.
- Hartert TV, et al. Risk factors for recurrent asthma hospital
visits and death among a population of indigent older adults with
asthma. Ann Allergy Asthma Immunol. 2002;89: 467–73.
- Price D, et al. Asthma control and management in 8,000 European
patients: the REcognise Asthma and LInk to Symptoms and Experience
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- World Allergy Organization (WAO). The management of severe
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https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php
[Last accessed: December 2021].
- Menzies-Gow A, et al. NAVIGATOR: a phase 3 multicenter,
randomized, double-blind, placebo-controlled, parallel-group trial
to evaluate the efficacy and safety of tezepelumab in adults and
adolescents with severe, uncontrolled asthma. Respir Res. 2020;21:
266.
- Wechsler ME, et al. Oral corticosteroid-sparing effect of
tezepelumab in adults with severe asthma. Am J Respir Crit Care
Med. 2021;203: A1197.
- Weschler ME, et al. SOURCE: A Phase 3, multicenter, randomized,
double-blind, placebo-controlled, parallel group trial to evaluate
the efficacy and safety of Tezepelumab in reducing oral
corticosteroid use in adults with oral corticosteroid dependent
asthma. Respir Res. 2020; 21: 264.
- Clinicaltrials.gov. Extension Study to Evaluate the Safety and
Tolerability of Tezepelumab in Adults and Adolescents With Severe,
Uncontrolled Asthma (DESTINATION) [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed:
July 2021].
- Diver S et al. Effect of tezepelumab on airway inflammatory
cells, remodelling, and hyperresponsiveness in patients with
moderate-to-severe uncontrolled asthma (CASCADE): a double-blind,
randomised, placebo-controlled, phase 2 trial. Lancet Respir
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- Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms,
Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9:
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- Li Y, et al. Elevated Expression of IL-33 and TSLP in the
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