Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild 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.

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.

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.