Symbicort gets US OK for asthma maintenance

Anglo-Swedish drugmaker AstraZeneca says that the US Food and Drug Administration has approved Symbicort (budesonide/formoterol) as maintenance therapy for asthma patients over the age of 12. Specifically, the approval covers dosages of the drug which contain 80mcg/4.5mcg or 160mcg/4.5mcg of budesonide and formoterol, respectively, to both control and treat the symptoms of the disease.

The firm added that the FDA's approval is based on results from a total of 27 Phase I, II and III trials, which established Symbicort's safety when delivered via a metered-dose inhaler. The trial data showed that both dosages of the product conferred a greater improvement in lung function in comparison with either components individually, or placebo. The company added that the assessment program had also demonstrated that the combination product brought about its effect more rapidly than any of the other compounds examined.

AstraZeneca said that, despite the FDA's decision, and the widespread marketing approval that the product has received, it still intended to keep to the scheduled 2007 US launch date. Financial analysts at Lehman Brothers said that, when introduced to the US market, the product could achieve peak sales of $1.5 billion per year.