AstraZeneca has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler (pMDI) for the long-term maintenance treatment of asthma in paediatric patients ages six to 11 years.
The FDA stated that AstraZeneca did not provide adequate data to establish the appropriate dose or doses of the individual components of Symbicort - budesonide and formoterol - and to establish how the individual components contribute to the combination product, in paediatric patients ages six to 11 years. AstraZeneca is evaluating the CRL and will provide a response to the Agency in due course.
Symbicort was approved in the US in July 2006 for the long-term maintenance treatment of asthma in patients 12 years of age and older and in February 2009 for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The CRL has no impact on the current prescribing information for the treatment of patients taking Symbicort for approved indications in asthma and COPD.
In the US, Symbicort is indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older. Administered twice daily, Symbicort is a combination of two proven respiratory medications - budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). Symbicort 160/4.5 mcg is also indicated for the maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. For patients with COPD, the approved dosage of Symbicort is 160/4.5 mcg two inhalations twice daily.