FDA approved Symbicort for kids 6 to 12 years with uncontrolled asthma.
The US Food and Drug Administration (FDA) approved inhalation aerosol budesonide/formoterol fumarate dehydrate (Symbicort/ AstraZeneca) (80/4.5 mcg) for children 6 to 12 years with asthma symptoms that is uncontrolled with low doses of inhaled corticosteroids.
Symbicort combines the inhaled corticosteroid budesonide (80 mcg) and the long acting beta 2-agonist formoterol fumarate dehydrate (4.5 mcg), and has already been approved in the US to treat asthma in patients 12 years and older and airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Experts highlighted that Symbicort is not indicated for patients with acute bronchospasm.
The approval for the latest indication was based on the ChildHood Asthma Safety and Efficacy (CHASE) clinical trial program that included the CHASE 3 phase 3 trial. The CHASE 3 trial showed that when delivered in a single pressured meter-dose inhaler, Symbicort 80/4.5 mcg significantly improved lung function in children 6 to 12 years, and can potentially provide treatment for a “wider range of patients suffering from asthma”.
The most commonly reported adverse events included headache, pharyngitis, rhinitis, and upper respiratory tract infection. Officials explained in the news release that Symbicort is not a rescue medication and should not replace fast-acting inhalers to treat acute asthmatic symptoms.