The US Food and Drug Administration has approved AstraZeneca's Symbicort inhalation aerosol (80/4.5 mcg) for children aged 6 to 12 years with asthma that is not well controlled with an inhaled corticosteroid, the company has announced.
Symbicort combines the inhaled corticosteroid budesonide (80 mcg) with the long-acting beta2-agonist formoterol fumarate dihydrate (4.5 mcg).
The approval of Symbicort 80/4.5 mcg in children as young as 6 years was based on the ChildHood Asthma Safety and Efficacy (CHASE) clinical trial program, which included the CHASE 3 phase 3 trial, AstraZeneca said in a news release.
This trial showed that Symbicort 80/4.5 mcg, delivered in a single pressured metered-dose inhaler (pMDI), improved lung function in children aged 6 to 12 years with asthma symptoms despite treatment with a low-dose inhaled corticosteroid vs budesonide pMDI 80 mcg, both delivered as two inhalations twice daily, the company notes.
The safety profile of Symbicort 80/4.5 mcg in children aged 6 to 12 years is similar to the safety profile in patients aged 12 years and older, the company says.
Symbicort 80/4.5 and 160/4.5 are already approved in the United States for patients aged 12 years and older with asthma. Symbicort 160/4.5 is also approved for the maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease. Symbicort is not indicated for the relief of acute bronchospasm.
An estimated 6.3 million children have been diagnosed with asthma in the United States, according to federal health officials.
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Cite this: FDA OKs Symbicort for Uncontrolled Asthma in Kids 6 to 12 - Medscape - Jan 30, 2017.