AstraZeneca announced that the US Food and Drug Administration (FDA) 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. 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 Chronic Obstructive Pulmonary Disease (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.
Gregory Keenan, Vice President, Medical Affairs and US Head Medical Officer, said:
“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.”
With this expanded indication, SYMBICORT can now be used to treat a wider range of patients suffering from asthma. 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.
An estimated 6.3 million children under the age of 18 years in the US have been diagnosed with asthma. Well-controlled asthma results in the prevention of symptoms such as coughing or wheezing and can help maintain good lung function and normal activity.
Filed Under: Drug Discovery