January 26, 2021: “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.
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.
Asthma affects an estimated 46 million adults in China, including an estimated 34 million with mild asthma.
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.
It is characterised by recurrent breathlessness and wheezing which varies over time, and in severity and frequency from person to person.
All asthma patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.
There are an estimated 176 million asthma exacerbations globally per year; these are physically threatening and emotionally significant for many patients.
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.
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.
The Global Initiative for Asthma no longer recommends SABA taken as-needed as the preferred reliever therapy.
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.
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.
Results from SYGMA 1 were published in The New England Journal of Medicine.
SYGMA 2 evaluated Symbicort Turbuhaler (200/6mcg*) as-needed, compared with budesonide (200mcg**) twice-daily maintenance plus terbutaline (0.5mg†) as-needed.
Results were published in The New England Journal of Medicine.
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).”
