a8902m
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of January 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Symbicort approved in China for mild asthma
26 January 2021 07:00 GMT
Symbicort
Turbuhaler approved in
China as an anti-inflammatory reliever in mild
asthma
Symbicort Turbuhaler becomes the first dual-combination therapy
approved in China for mild, moderate and severe asthma
AstraZeneca's Symbicort
Turbuhaler (budesonide/formoterol 160/4.5mcg) has been
approved in China as an anti-inflammatory reliever to be taken
as-needed in response to symptoms to achieve asthma control in
patients with mild asthma aged 12 years and
older.
The approval by the National Medical Products Administration (NMPA)
was based on positive results from the SYGMA
1 and SYGMA
2 Phase III trials,
published in The New England Journal of
Medicine, which evaluated the
efficacy of Symbicort
Turbuhaler taken as-needed
as an anti-inflammatory reliever compared with standard of care
(SoC) therapies in mild asthma. SoC included short-acting
beta2-agonist (SABA) taken as-needed or regular maintenance
controller therapy (twice-daily budesonide, an inhaled
corticosteroid (ICS)) plus SABA taken as-needed.1,2
Symbicort Turbuhaler is
the first dual-combination therapy approved in China as an
anti-inflammatory reliever to treat mild asthma. It is already
approved in China for patients with moderate to severe asthma as an
anti-inflammatory reliever plus maintenance therapy, and as
maintenance therapy only.
Asthma is a chronic, variable, inflammatory disease which can cause
asthma attacks and symptoms including breathlessness and
wheezing.3 Asthma
affects an estimated 46 million adults in China, including an
estimated 34 million with mild asthma.4,5
Professor Xin Zhou, Vice President of the 10th China Thoracic
Society and the respiratory discipline leader, Shanghai General
Hospital, China, said: "This approval aligns to the latest National
Asthma Guidelines from the Chinese Thoracic Society as well as
international recommendations from the Global Initiative for Asthma
which recommend a low dose corticosteroid-formoterol combination
therapy taken as-needed as the preferred reliever therapy in mild
asthma. Now doctors in China can prescribe Symbicort
Turbuhaler to reduce the
impact of asthma on their patients with mild, moderate and severe
disease."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Everyone with asthma is at risk of an attack,
regardless of their age, disease severity, adherence to treatment
or level of control. This approval means people with mild
asthma in China can now take Symbicort
Turbuhaler as an
anti-inflammatory reliever to treat their symptoms and also to
reduce the likelihood of an attack by treating the underlying
inflammation in their airways. This approval builds
on Symbicort's established role in treating moderate to
severe disease."
The safety and tolerability data for Symbicort
Turbuhaler in the SYGMA
trials were consistent with the known profile of the
medicine.1,2
Symbicort is a combination
of an ICS that treats underlying inflammation and a long-acting
beta2-agonist (LABA) bronchodilator with a fast onset of action in
a single inhaler. Symbicort
Turbuhaler has been
approved as an anti-inflammatory reliever taken as-needed in mild
asthma in 35 countries, and regulatory reviews are ongoing in
additional countries.
Asthma
Asthma is a common chronic respiratory disease, and it affects the
health and day-to-day lives of as many as 339 million adults and
children worldwide.6 It
is characterised by recurrent breathlessness and wheezing which
varies over time, and in severity and frequency from person to
person.3
All asthma patients are at risk of severe exacerbations regardless
of their disease severity, adherence to treatment or level of
control.7,8,9 There
are an estimated 176 million asthma exacerbations globally per
year;10 these
are physically threatening and emotionally significant for many
patients.11 However,
despite asthma being a chronic, variable inflammatory disease, many
patients are either under-prescribed or under-use their
anti-inflammatory maintenance therapy and may over-rely on their
SABA reliever, which can mask symptom worsening.12,13,14,15 Taking
a SABA inhaler alone during a worsening of symptoms does not
address the underlying inflammation, leaving patients at risk of
asthma exacerbations and potential exposure to frequent bursts of
oral corticosteroids.16 The
Global Initiative for Asthma no longer recommends SABA taken
as-needed as the preferred reliever therapy.17
SYGMA
The Symbicort Given as-needed in Mild Asthma (SYGMA) trial programme comprised SYGMA
1 and 2: two 52-week Phase III trials in more than 8,000
patients.18 SYGMA
1 evaluated Symbicort
Turbuhaler (200/6mcg*)
as-needed, compared with terbutaline (0.5mg†)
as-needed and budesonide (200mcg**)
twice-daily plus terbutaline (0.5mg†)
as-needed.1 Results
from SYGMA 1 were published in The
New England Journal of Medicine.1 SYGMA
2 evaluated Symbicort
Turbuhaler (200/6mcg*)
as-needed, compared with budesonide (200mcg**)
twice-daily maintenance plus terbutaline (0.5mg†)
as-needed.2 Results
were published in The
New England Journal of Medicine.2
Symbicort
Symbicort (budesonide/formoterol) is the number one
ICS/LABA combination therapy in asthma and chronic obstructive
pulmonary disease (COPD) in China. It is a combination formulation
containing budesonide, an ICS that treats underlying inflammation,
and formoterol, a LABA with a fast onset of action, in a single
inhaler. Symbicort was launched in 2000 and is approved in
approximately 120 countries to treat asthma and/or COPD either
as Symbicort
Turbuhaler or Symbicort pMDI (pressurised metered-dose
inhaler).
Symbicort Turbuhaler is
the first dual-combination therapy approved in China as an
anti-inflammatory reliever to treat mild asthma. It is already
approved in China for patients with moderate to severe asthma as an
anti-inflammatory reliever plus maintenance therapy (12 years and
older) and as maintenance therapy only (six years and
older).
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology is one of AstraZeneca's three therapy
areas and is a key growth driver for the Company.
AstraZeneca is an established leader in respiratory care, and its
inhaled and biologic medicines reached more than 53 million
patients in 2019. Building on 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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global,
science-led biopharmaceutical company that focuses on the
discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three therapy
areas - Oncology, 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. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
* Corresponds to a delivered dose of budesonide/formoterol of
160/4.5mcg.
** Corresponds to a delivered dose of budesonide of
160mcg.
† Corresponds to a delivered dose of terbutaline of 0.4mg,
delivered by a Turbuhaler.
References
1. O'Byrne PM, FitzGerald JM, Bateman
ED, et
al. Inhaled combined
budesonide-formoterol as needed in mild
asthma. N Engl J
Med. 2018; 378:
1865-1876.
2. Bateman ED, Reddel HK, O'Byrne
PM, et
al. As-needed
budesonide-formoterol versus maintenance budesonide in mild
asthma. N Engl J
Med. 2018; 378:
1877-1887.
3.
National Heart, Lung, and Blood Institute. Guidelines for the
Diagnosis and Management of Asthma (EPR-3). [Online]. Available at:
https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma.
[Accessed December 2020]
4. Huang K, Yang T, Xu
J, et
al. Prevalence, risk factors,
and management of asthma in China: a national cross-sectional
study. Lancet. 2019; 394:407-418.
5. Ding B, Small M, Wang W, et al. The
disease burden of mild asthmatics in
China. European
Respiratory Journal. 2016;
48 (suppl 60): PA4208.
6.
The Global Asthma Network. The Global Asthma Report 2018. [Online].
Available at: http://www.globalasthmanetwork.org/. [Accessed
December 2020]
7. Olaguibel JM, Quirce S, Julia
B, et
al. Measurement of asthma
control according to Global Initiative for Asthma guidelines: a
comparison with the Asthma Control
Questionnaire. Respir Res. 201; 13: 50.
8. 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; 24:
14009.
9. Bateman ED, Hurd SS, Barnes PJ, et
al. Global strategy for asthma management and prevention: GINA
executive summary. Eur Respir
J. 2008; 31:
143-78.
10.
AstraZeneca Pharmaceuticals. Data on file. Budesonide/formoterol:
Annual Rate of Exacerbations Globally
(ID:SD-3010-ALL-0017).
11. Sastre J, Fabbri LM, Price
D, et
al. Insights, attitudes,
and perceptions about asthma and its treatment: a multinational
survey of patients from Europe and Canada. World Allergy Organ
J. 2016; 9:
13.
12. Humbert M, Andersson TL, Buhl R.
Budesonide/formoterol for maintenance and reliever therapy in the
management of moderate to severe asthma. Allergy. 2008; 63: 1567-80.
13. Rabe KF, Vermeire PA, Soriano JB, Maier
WC. Clinical management of asthma in 1999: the asthma insights and
reality in Europe (AIRE) study. Eur Respir
J. 2000; 16:
802-7.
14. Tattersfield AE, Postma DS, Barnes
PJ, et
al. on behalf of the FACET
International Study Group. Exacerbations of asthma: a descriptive
study of 425 severe exacerbations. Am J Respir Crit Care
Med. 1999; 160:
594-9.
15. Adams RJ, Fuhlbrigge A, Guilbert
T, et
al. Inadequate use of asthma
medication in the United States: results of the asthma in America
national population survey. J Allergy Clin
Immunol. 2002; 110:
58-64.
16. Price DB, Trudo F, Voorham J, et al.
Adverse outcomes from initiation of systemic corticosteroids for
asthma: long-term observational study. J Asthma
Allergy. 2018; 11:
193-204.
17.
Global Initiative for Asthma. 2020 GINA Report, Global Strategy for
Asthma Management and Prevention. [Online]. Available at:
https://ginasthma.org/gina-reports/. [Accessed December
2020]
18. O'Byrne PM, FitzGerald JM, Zhong
N, et
al. The SYGMA programme of
phase 3 trials to evaluate the efficacy and safety of
budesonide/formoterol given "as needed" in mild asthma: study
protocols for two randomised controlled
trials. Trials. 2017; 18: 12.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
26 January
2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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