The US FDA has approved Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms for the treatment of asthma in pediatric patients aged six up to 12 years, according to the manufacturer AstraZeneca.

Symbicort is an ICS/LABA (inhaled corticosteroid/long-acting beta2-agonist bronchodilator) controller medication that has been shown to help control asthma by reducing inflammation in the lungs and keeping airways open. It is not indicated for the relief of acute bronchospasm. Symbicort 80/4.5 and 160/4.5 are already approved in the US to treat asthma in patients 12 years and older. Symbicort 160/4.5 is also approved for the maintenance treatment of airflow obstruction in COPD in adults.

The FDA approval is based on the CHASE (ChildHood Asthma Safety and Efficacy) clinical trial program, which included the CHASE 3 Phase III trial. This trial demonstrated Symbicort 80/4.5 micrograms delivered in a pressurized metered-dose inhaler (pMDI) significantly improved lung function in pediatric patients with asthma aged six up to 12 years who were symptomatic on low-dose inhaled corticosteroid versus budesonide pMDI 80 micrograms, both delivered as two inhalations twice daily.

The safety profile in pediatric patients aged six up to 12 years is similar to the safety profile in patients aged 12 years and older. Common adverse reactions that occurred in patients treated with Symbicort 80/4.5 with a frequency of ?3% and more frequently than patients treated only with budesonide pMDI 80 micrograms included upper respiratory tract infection, pharyngitis, headache, and rhinitis.

“Symbicort is a cornerstone product in our growing respiratory franchise and we are pleased to now be able to offer this medicine to younger patients, helping to control and prevent asthma symptoms,” said Gregory Keenan, vice president, Medical Affairs and US head medical officer, AstraZenaca.

More information, including full prescribing Information, including boxed warning and medication guide is available at the AstraZenaca website.