TIDMAZN
RNS Number : 8851M
AstraZeneca PLC
26 January 2021
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
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Contacts
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* 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
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