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 that included 1,446 children ages six to 11 years old with asthma.
AstraZeneca’s Symbicort is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.
Howard Hutchinson, chief medical officer of AstraZeneca, said: “This supplemental new drug application (sNDA) submission is another important milestone for Symbicort, and we look forward to discussions with the FDA about the potential indication for children.”