A phase III study of its Symbicourt asthma inhalers showed a significant breathing improvement in children aged between 6-12, AstraZeneca reported (LON:AZN).
The improvement demonstrated the drug's appropriateness as a step-up therapy in young children, Astra said.
AstraZeneca conducted the study (CHASE 3) after the US Food and Drug Administration (FDA) requested additional data on the effect of the two components budesonide and formoterol in young asthma patients.
Gregory Keenan, Vice President, Medical Affairs and US Head Medical Officer, said: “These safety and efficacy results from the CHASE 3 study indicate Symbicourt may offer an important asthma treatment option for the appropriate pediatric populations.
“We look forward to working with the regulatory authorities to help make Symbicourt available to this population of children with asthma.”