Pediatric asthma is diagnosed in nearly 9 million children in the United States. It accounts for 13 million missed days of school and is the second leading respiratory disease to cause hospitalization of children. The annual direct health care cost of the disease for children and adults is approximately $14.7 billion; indirect costs are nearly $20 billion.
Many long-term asthma maintenance treatments are approved for patients older than 12; now, AstraZeneca, Wilmington, Del, has submitted a supplemental New Drug Application (sNDA) to the FDA for approval of a new indication for SYMBICORT® (budesonide/formoterol fumerate dihydrate) inhalation aerosol for the long-term maintenance treatment of asthma in patients between the ages of 6 and 11 years of age.
The submission comes after a development program comprising five active or placebo-controlled Phase III trials assessing the efficacy and safety of the drug in 1,446 children.
Lead investigator, Jeffrey Leflein, MD, Allergy & Immunology Associates of Ann Arbor Michigan said, “SYMBICORT could potentially offer another treatment option for the long-term maintenance of asthma in young children whose condition is not adequately controlled with inhaled corticosteroids alone.”