The FDA approval is based on results from two pivotal clinical trials, Shine (six-month) and Sun (12-month), which found Symbicort significantly improved lung function within five minutes of the first dose and sustained that lung function improvement for the duration of the studies.
Howard Hutchinson, chief medical officer of AstraZeneca, said: “With the approval of Symbicort in chronic obstructive pulmonary disease (COPD), patients have a new treatment option that can deliver lung function improvement and daily symptom control, together with a rapid onset of action.”