The FDA has approved Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol 80/4.5 mcg (AstraZeneca) for the treatment of asthma in pediatric patients 6 to 12 years of age. Symbicort (80/4.5 mcg and 160/4.5 mcg) is already approved in the United States to treat asthma patients 12 years of age and older. Symbicort 160/4.5 mcg is also approved for the maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD).
The FDA’s approval was based on data from the CHASE (ChildHood Asthma Safety and Efficacy) clinical trial program, which included the CHASE 3 trial. In that phase 3 study, budesonide/formoterol 80/4.5 mcg administered in a pressurized metered-dose inhaler (pMDI) significantly improved lung function in pediatric asthma patients 6 to 12 years of age who were symptomatic on low-dose inhaled corticosteroids compared with budesonide pMDI 80 mcg, both delivered as two inhalations twice daily. The safety profile in pediatric patients 6 to 12 years of age was similar to that in patients 12 years of age and older. The most common adverse events observed in patients treated with budesonide/formoterol 80/4.5 included upper respiratory tract infections, pharyngitis, headache, and rhinitis.
Symbicort is an inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) bronchodilator controller medication that has been shown to help control asthma by reducing inflammation in the lungs, thus keeping airways open. The product is not indicated for the relief of acute bronchospasm.
An estimated 6.3 million children and adolescents younger than 18 years of age in the U.S. have been diagnosed with asthma. Well-controlled asthma results in the prevention of symptoms, such as coughing and wheezing, and can help maintain lung function and normal activity.
Source: AstraZeneca; January 30, 2017.