AstraZeneca gets approval for Symbicort Turbuhaler in China

AstraZeneca said on Tuesday that ‘Symbicort Turbuhaler’, with budesonide and formoterol, 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 FTSE 100 drugmaking giant said the approval by the National Medical Products Administration (NMPA) was based on positive results from the ‘SYGMA 1’ and ‘SYGMA 2’ phase 3 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 therapies in mild asthma.

Standard-of-care included short-acting beta2-agonist (SABA) taken as needed, or regular maintenance controller therapy plus SABA taken as-needed.

AstraZeneca said Symbicort Turbuhaler is the first dual-combination therapy approved in China as an anti-inflammatory reliever to treat mild asthma.

It was 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,” said executive vice-president of biopharmaceuticals research and development Mene Pangalos.

“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."

At 0827 GMT, shares in AstraZeneca were up 0.66% at 7,949p.