AstraZeneca has submitted a New Drug Application (NDA) to the US FDA for approval of Symbicort (budesonide/formoterol) for the maintenance treatment of asthma.
Symbicort is a combination of budesonide (an inhaled corticosteroid) and formoterol (a rapid and long lasting ß2-agonist). Combination products containing an inhaled corticosteroid and a long-acting ß2-agonist are recommended by the National Asthma Education and Prevention Program (NAEPP) of the National Institute of Health for patients including those whose asthma is uncontrolled on inhaled steroid therapy alone, or for patients whose asthma is currently controlled on an inhaled steroid plus a separate inhaled long-acting ß2-agonist.
The Symbicort NDA submission is based on 27 Phase I, II and III trials designed to assess the efficacy and safety of Symbicort in a Metered Dose Inhaler (MDI). This application will be for maintenance treatment of asthma in patients age 12 and above. The NDA submission seeks approval for two strengths of Symbicort (80/4.5 and 160/4.5 microgram).
Symbicort is currently available in a dry powder inhaler device, Turbuhaler, in 93 countries around the world. The current worldwide market for fixed combination products is estimated to be worth over $6 billion, with approximately half of this potential market in the US.