AstraZeneca Submits an sNDA for SYMBICORT® for the Treatment of Asthma in Children as Young as Age Six

AstraZeneca today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the long-term maintenance treatment of asthma in paediatric patients ages 6 to 11 years old. SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.
“Millions of children in the U.S. are affected by asthma,” said lead investigator Jeffrey Leflein, MD, Allergy & Immunology Associates of Ann Arbor, Michigan. “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.”

The submission package is based on a robust clinical development program consisting of five active or placebo-controlled Phase III trials assessing the efficacy and safety of SYMBICORT pressurized metered-dose inhaler (pMDI) that included 1,446 children ages 6 to 11 years old with asthma. The proposed starting dose for children (80/9 mcg twice-daily) was studied in one pivotal randomized, double-blind, active-controlled, 12-week study that evaluated 256 children ages 6 to 11 years old with mild-to-moderate persistent asthma previously treated with inhaled corticosteroid therapy. In this study, SYMBICORT was compared to budesonide pMDI and formoterol dry powder inhaler. A second study evaluating this dose included 351 subjects ages 6 to 11 years old. Results from both studies demonstrated that SYMBICORT 80/9 mcg twice daily had a similar safety profile to one of the mono-components, budesonide; likewise, results from the first study also found that SYMBICORT 80/9 mcg twice daily had a similar safety profile to its other mono-component, formoterol. The most common adverse events reported were headache, pyrexia, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.