THOUSAND OAKS, Calif.,
Jan. 13, 2022 /PRNewswire/
-- Amgen (NASDAQ:AMGN) and AstraZeneca today announced
TEZSPIRE™ (tezepelumab-ekko) is now available for shipment to
wholesalers in the U.S. TEZSPIRE was approved by the U.S. Food and
Drug Administration (FDA) on Dec. 17,
2021 for the add-on maintenance treatment of adult and
pediatric patients aged 12 years and older with severe
asthma.1
"Severe asthma has historically been a complex disease for
patients to manage and for physicians to treat," said Murdo Gordon, executive vice president of Global
Commercial Operations at Amgen. "About 60 percent of people have
multiple drivers of disease and may not respond well to existing
treatments. TEZSPIRE was approved for a broad population of
people living with severe asthma, and we look forward to getting
this important medicine into the hands of millions of patients who
have had an unmet medical need."
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
for severe asthma that does not have a phenotype—eosinophilic or
allergic—or biomarker limitation within its approved
label.4-11 TEZSPIRE consistently and significantly
reduced asthma attacks across Phase 2 and 3 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).2,3
The most common adverse reactions (incidence ≥3% and more common
than placebo) of TEZSPIRE are pharyngitis, arthralgia, and back
pain.1
Amgen and AstraZeneca 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.
Amgen and AstraZeneca 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) 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 (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.
About the NAVIGATOR and the PATHFINDER Clinical Trial
Program
In addition to the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program
included two trials, NAVIGATOR and
SOURCE. 2,12-14 The program includes additional
mechanistic and long-term safety trials.15
NAVIGATOR is a Phase 3, 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 (ICS) plus at least
one additional controller medication with or without daily oral
corticosteroid 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.2
The primary efficacy endpoint was the 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.3
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).3 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).
The most frequently reported adverse events for TEZSPIRE were
nasopharyngitis, upper respiratory tract infection and
headache.2
NAVIGATOR is the first Phase 3 trial to show benefit in severe
asthma irrespective of eosinophils by targeting TSLP.2
These results support the U.S. Food and Drug Administration
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 U.S. for the
treatment of asthma by the FDA.
Patients who participated in our Phase 3 clinical trials were
eligible to continue in DESTINATION, a Phase 3 extension trial
assessing long-term safety and efficacy.16
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
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.3,17 TSLP is released in
response to multiple triggers associated with asthma exacerbations,
including allergens, viruses and other airborne
particles.3,17 Expression of TSLP is increased in
the airways of patients with asthma and has been correlated with
disease severity.3,18 Blocking TSLP may prevent the
release of pro-inflammatory cytokines by immune cells, resulting in
the prevention of asthma exacerbations and improved asthma
control.3,18 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.3,18
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 Severe Asthma
Globally, there are approximately
2.5 million patients with severe asthma who are uncontrolled or
biologic eligible, with approximately 1 million in
the U.S. Many patients with severe asthma have an
inadequate response to currently available biologics and oral
corticosteroids and thus fail to achieve asthma
control.19-24 Uncontrolled asthma occurs when
symptoms persist despite treatment. Severe, uncontrolled asthma is
debilitating with patients experiencing frequent exacerbations,
significant limitations on lung function and a reduced quality of
life.20-22 Patients with severe uncontrolled
asthma have twice the risk of asthma-related
hospitalizations.25,26 There is also a significant
socio-economic burden with these severe uncontrolled asthma
patients accounting for 50% of asthma-related
costs.28
Multiple inflammatory pathways are involved in the pathogenesis
of asthma.27-29 Eosinophilic asthma, and more
broadly, T2 inflammation-driven asthma, accounts for about
two-thirds of patients with severe asthma.29 These
patients are typically characterized as having elevated levels of
inflammatory biomarkers, including blood eosinophils, serum IgE and
FeNO.30,31 However, many patients do not fit the
criteria for eosinophilic or allergic asthma, may have unclear or
multiple drivers of inflammation, and may not qualify for or
respond well to a current biologic medicine.31
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.
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
2021, Amgen was named one of the 25 World's Best Workplaces™ by
Fortune and Great Place to Work™ and one of the 100 most
sustainable companies in the world by Barron's.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
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., Kyowa-Kirin Co., Ltd., or any
collaboration to manufacture therapeutic antibodies against
COVID-19), the performance of Otezla® (apremilast)
(including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), the Five Prime Therapeutics, Inc.
acquisition, or the Teneobio, Inc. 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
such as the ongoing COVID-19 pandemic on our business, 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. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments involving current and future products,
sales growth of recently launched products, competition from other
products including biosimilars, difficulties or delays in
manufacturing our products and global economic conditions. In
addition, sales of our products are affected by pricing pressure,
political and public scrutiny and reimbursement policies imposed by
third-party payers, including governments, private insurance plans
and managed care providers and may be affected by regulatory,
clinical and guideline developments and domestic and international
trends toward managed care and healthcare cost containment.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. We or others could
identify safety, side effects or manufacturing problems with our
products, including our devices, after they are on the market. Our
business may be impacted by government investigations, litigation
and product liability claims. In addition, our business may be
impacted by the adoption of new tax legislation or exposure to
additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities,
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. 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, 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. A breakdown, cyberattack or information security breach
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. 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.
CONTACT: Amgen, Thousand Oaks
Michael Strapazon, 805-313-5553
(media)
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060
(investors)
References
- TEZSPIRE (tezepelumab) U.S. prescribing information;
2021.
- Corren J, et al. Tezepelumab in adults with uncontrolled asthma
[supplementary appendix; updated April 18,
2019]. N Engl J Med. 2017; 377: 936-946.
- 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.
- Hanania NA, et al. Omalizumab in severe allergic asthma
inadequately controlled with standard therapy: a randomized trial.
Ann Intern Med. 2011;154 (9): 573-82.
- Yancey SW, et al. Disease burden and efficacy of
mepolizumab in patients with severe asthma and blood eosinophil
counts of ≥150-300 cells/μL. Respir Med. 2019; 151:
139-141.
- FitzGerald JM, et al. Predictors of enhanced response
with benralizumab for patients with severe asthma: pooled analysis
of the SIROCCO and CALIMA studies. Lancet Respir Med. 2018;
6 (1): 51-64.
- Castro M, et al. Dupilumab Efficacy and Safety in
Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018;
378 (26): 2486-2496.
- Ortega HG, et al; on behalf of the MENSA Investigators.
Mepolizumab treatment in patients with severe eosinophilic asthma.
N Engl J Med. 2014;371(13):1198-207.
- Bleecker ER, et al, on behalf of the SIROCCO study
investigators. Efficacy and safety of benralizumab for patients
with severe asthma uncontrolled with high-dosage inhaled
corticosteroids and long-acting beta2-agonists (SIROCCO): a
randomised, multicentre, placebo-controlled phase 3 trial.
Lancet 2016: 388 (10056): 2115-2127.
- FitzGerald JM, et al, on behalf of the CALIMA study
investigators. Benralizumab, an anti-interleukin-5 receptor alpha
monoclonal antibody, as add-on treatment for patients with severe,
uncontrolled, eosinophilic asthma (CALIMA): a randomised,
double-blind, placebo-controlled phase 3 trial. Lancet.
2016: 388(10056): 2128-2141.
- Wenzel S, et al. Dupilumab efficacy and safety in adults
with uncontrolled persistent asthma despite use of
medium-to-high-dose inhaled corticosteroids plus a long-acting β2
agonist: a randomised double-blind placebo-controlled pivotal phase
2b dose-ranging trial. Lancet.
2016 Jul 2;388(10039):31-44
- Menzies-Gow A, et al. NAVIGATOR: a phase 3
multicentre, 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,
multicentre, 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. Efficacy and Safety of Tezepelumab in
Participants With Severe Chronic Rhinosinusitis With Nasal
Polyposis (WAYPOINT). Available at:
https://clinicaltrials.gov/ct2/show/NCT04851964. [Last accessed:
July 2021].
- 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].
- 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.
- Centers for Disease Control and Prevention. Most Recent
National Asthma Data. Available at:
https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm.
Accessed September 23, 2021
- Wenzel S. Severe Asthma in Adults. Am J Respir Crit Care
Med. 2005;172;149–60.
- Chung KF, et al. International ERS/ATS guidelines on
definition, evaluation and treatment of severe asthma. Eur
Respir J. 2014; 43: 343–73.
- Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts:
what can they teach us about severe asthma? J Intern Med
2012;272:121–32.
- Chastek et al. J Manag Care Spec Pharm
2016;22:848-861.
- Chen et al. Curr Med Res Opin
2018;34(12):2075-2088.
- Price D, Fletcher M, van der Molen T. Asthma control and
management in 8,000 European patients: the Recognise Asthma and
Link to Symptoms and Experience (REALISE) survey. NPJ Prim Care
Respir Med. 2014; 12; 24: 14009.
- World Allergy Organization (WAO). The management of severe
asthma: economic analysis of the cost of treatments for severe
asthma. Available at:
https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php
[Last accessed: April 2021].
- Godar M, Blanchetot C, de Haard H, et al. Personalized medicine
with biologics for severe type 2 asthma: current status and future
prospects. MAbs. 2018; 10 (1): 34–45.
- Rabe KF, Busse W, Pavord I, Castro M. Raising the clinical bar
beyond current biologics in uncontrolled persistent asthma:
translating emerging data in future clinical decisions. EMJ
Allergy Immunol. 2018; 3: 60-9.
- Peters MC, Mekonnen ZK, Yuan S, et al. Measures of gene
expression in sputum cells can identify TH2-high and TH2-low
subtypes of asthma. J Allergy Clin Immunol. 2014; 133:
388–94.
- Clinicaltrials.gov. Study to Evaluate the Efficacy and Safety
of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With
Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Available
at: https://clinicaltrials.gov/ct2/show/NCT03406078. [Last
accessed: April 2021].
- Fahy JV. Type 2 inflammation in asthma--present in most, absent
in many. Nat Rev Immunol. 2015; 15: 57-65.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/tezspire-tezepelumab-ekko-now-available-in-the-united-states-for-the-treatment-of-severe-asthma-301460118.html
SOURCE Amgen