ICS/LABA Controller Med Approved for Pediatric Asthma
The US Food and Drug Administration has approved SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms 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 US to treat asthma in patients 12 years and older. Symbicort 160/4.5 is also approved for the maintenance treatment of airflow obstruction in Chronic Obstructive Pulmonary Disease (COPD) in adults.
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Asthma affects more than 6 million children under the age of 18 years in the United States. Early and effective treatment of the condition can limit symptoms such as coughing or wheezing and help patients maintain good lung function and normal activity.
The decision to approve Symbicort for use in younger patients is based on results from the CHASE (ChildHood Asthma Safety and Efficacy), which demonstrated that treatment with Symbicort 80/4.5 micrograms delivered in a pressurized metered-dose inhaler (pMDI) could significantly improve lung function in pediatric patients with asthma aged 6 to 12 years compared with budesonide pMDI 80 micrograms,both delivered as two inhalations twice daily.
The safety profile of Symbicort in pediatric patients was also similar to what has been observed in adult patients, with the most common adverse events being upper respiratory tract infection, pharyngitis, headache, and rhinitis.
“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 Gregory Keenan, vice president, medical affairs and US head medical officer at AstraZeneca.
Symbicort is a combination formulation containing budesonide, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta2-agonist bronchodilator (LABA), in a single inhaler, which have been shown to help control asthma by reducing inflammation in the lung.—Sean McGuire
Reference
US FDA approves SYMBICORT for the treatment of asthma in pediatric patients [press release]. AstraZeneca global site; 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. Accessed January 30, 2017.
