FDA Approves New Option for Pediatric Asthma

The FDA has approved Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 for the treatment for the treatment of asthma in pediatric patients aged 6 to 12 years.

Symbicort 80/4.5 and 160/4.5 are already approved in the United States for the treatment of patients with asthma aged 12 years or older. Symbicort 160/4.5 is also approved for maintenance of chronic obstructive pulmonary disease (COPD) in adults.

The approval of the new dosage comes in response to the ChildHood Asthma Safety and Efficacy (CHASE) clinical trial program, specifically the results of the CHASE 3 Phase III trial, which demonstrated that Symbicort 80/4.5 significantly improved lung function in pediatric patients with asthma aged 6 to 12 years who were symptomatic on low-dose inhaled corticosteroids versus budesonide pMDI 80 micrograms.

Common adverse events that occurred included upper respiratory tract infection, pharyngitis, headache, and rhinitis.

—Michael Potts

Reference:

AstraZeneca. US FDA approves Symbicort for the treatment of asthma in pediatric patients [press release]. January 30, 2017. https://www.astrazeneca-us.com/media/press-releases/2017/us-fda-approves-symbicort-for-the-treatment-of-asthma-in-pediatric-patients-01302017.html.