Symbicort was approved in July 2006 for patients over 12 years old for the long-term maintenance treatment of asthma, and for the treatment of patients with chronic diseases such as emphysema in February 2009.

 

AstraZeneca is now seeking to sell the drug for the long-term maintenance treatment of asthma in 6-11 year-olds, but the Food and Drug Administration said the company had not provided adequate data to establish the appropriate dose or doses of the drug’s two components – budesonide and dormoterol – in this younger age group.

 

The FDA’s Complete Response Letter further said that, given the circumstances, the agency is not ready to approve the drug. AstraZeneca is evaluating the letter and “will provide a response to the agency in due course,” the drugmaker said in a statement.

 

Asthma is a chronic disease involving the respiratory system in which the airways occasionally constrict, become inflamed, and are lined with excessive amounts of mucus, often as a response to one or more triggers, such as exposure to an environmental stimulant (e.g. an allergen, environmental tobacco smoke, cold or warm air, perfume, pet dander, moist air) or even emotional stress.

 

The number of children with asthma has more than doubled since the 1980s. According to the Centers for Disease Control and Prevention estimates, about 20 million Americans have asthma, including 9 million children.