China approval for Symbicort Turbuhaler in mild asthma

Symbicort Turbuhaler (budesonide/formoterol), one of Anglo-Swedish drugmaker AstraZeneca (LSE: AZN) top-selling drugs, 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.