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AstraZeneca’s Symbicort Turbuhaler approved in China

Mene Pangalos

AstraZeneca’s Symbicort Turbuhaler 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 TheNew 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.

The first dual-combination therapy approved in China as an anti-inflammatory reliever to treat mild asthma

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.

“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,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.

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.

Photo of Mene Pangalos: AstraZeneca