AstraZeneca’s Mild Asthma Drug Wins Approval in China
China’s National Medical Products Administration has granted AstraZeneca’s (AZ) Symbicort Turbuhaler (budesonide/formoterol) approval for use in controlling mild asthma in patients 12 years and older.
The regulatory approval was supported by positive results in two late-stage trials that compared the efficacy of the anti-inflammatory product to standard-of-care therapies for mild asthma, including short-acting beta2-agonist (SABA) or regular maintenance-controller therapy (twice-daily budesonide) plus SABA.
According to AZ, the approval marks China’s first for a dual-combination therapy as an anti-inflammatory for mild asthma. The combo was already approved in the country for patients with moderate-to-severe asthma as an anti-inflammatory plus maintenance therapy and as a maintenance therapy on its own.