Officials with AstraZeneca recently announced that the FDA has expanded the indication of its 80/4.5 mcg budesonide and formoterol fumarate dihydrate inhalation aerosol (Symbicort), approving the drug for the treatment of asthma in patients aged 6 to 12 years.
Symbicort 80/4.5 was previously approved for the treatment of asthma in patients aged 12 and older. A 160/4.5 version of the inhaler, indicated for this purpose as well as for the treatment of chronic obstructive pulmonary disease (COPD) in adults, is also available.
The agency’s latest approval was based on data from a late-stage trial in which the use of Symbicort 80/4.5 was associated with improved lung function in pediatric patients with asthma aged 6 to 12 years.
“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 AstraZeneca vice president Gregory Keenan in a press release.
Adverse events reported by trial participants treated with Symbicort include upper respiratory tract infections, pharyngitis, headaches, and rhinitis.