AstraZeneca has secured China’s National Medical Products Administration (NMPA) approval for its anti-inflammatory reliever Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) to control symptoms of asthma in patients aged 12 years and older.

Symbicort is a combination therapy, comprising budesonide, an ICS that targets inflammation and formoterol, a long-acting beta2-agonist (LABA) in a single inhaler, intended for asthma and chronic obstructive pulmonary disease (COPD).

The British drugmaker said that its Symbicort Turbuhaler is the first dual-combination therapy approved as an anti-inflammatory reliever in China for the treatment of mild asthma.

Also, it has been approved as an anti-inflammatory reliever for mild asthma in 35 countries, with regulatory reviews underway in additional countries.

AstraZeneca BioPharmaceuticals R&D executive vice president Mene Pangalos 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 NMPA approval was based on positive results from the Phase 3 SYGMA 1 and SYGMA 2 studies, a part of Symbicort Given as-needed in Mild Asthma (SYGMA) trial programme.

The Phase 3 studies compared the efficacy of Symbicort Turbuhaler taken as-needed as an anti-inflammatory reliever, with the standard of care (SoC) therapies in mild asthma.

SoC therapies in the study include short-acting beta2-agonist (SABA) taken as-needed or regular maintenance controller therapy (budesonide) plus SABA was taken as-needed.

The company said that its Symbicort Turbuhaler demonstrated a consistent safety and tolerability with the known profile of the medicine.

Shanghai General Hospital respiratory discipline leader Xin Zhou 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.”