Wilmington, DE June 4, 2008 AstraZeneca (NYSE: AZN) 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 pediatric 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 asthma1," 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.2 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.3 In this study, SYMBICORT was compared to budesonide pMDI and formoterol dry powder inhaler.3 A second study evaluating this dose included 351 subjects ages 6 to 11 years old.4 Results from both studies demonstrated that SYMBICORT 80/9 mcg twice daily had a similar safety profile to one of the mono-components, budesonide;4,5 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.5 The most common adverse events reported were headache, pyrexia, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.2
"This sNDA submission is another important milestone for SYMBICORT, and we look forward to discussions with the FDA about the potential indication for children," said Howard Hutchinson, Chief Medical Officer, AstraZeneca. "AstraZeneca remains committed to advancing the treatment of asthma in adult and pediatric patients."
|Contact: Katie Neff|
Edelman Public Relations