FDA expands indication of Symbicort for pediatric patients with asthma

The FDA extended approval for Symbicort Inhalation Aerosol 80/4.5 micrograms to treat asthma in pediatric patients aged 6 to 12 years, lowering the age restrictions in the U.S., based on data from the ChildHood Asthma Safety and Efficacy clinical trial program.

Results from the international, multicenter ChildHood Asthma Safety and Efficacy (CHASE) 3 phase III trial, showed that Symbicort 80/4.5 mcg dispensed in a pressurized meter-dose inhaler (pMDI) significantly improved lung function in pediatric patients with asthma aged 6 to 12 years who were symptomatic on low-dose inhaled corticosteroid compared with budesonide pMDI 80 mcg when both are delivered as 2 inhalations twice a day.

FDA reports that the safety profile for Symbicort 80/4.5 in pediatric patients aged 6 to 12 years resembles the safety profile in patients aged 12 years and older, which along with Symbicort 160/4.5 mcg, was already approved in the U.S. to treat asthma. Common adverse outcomes included upper respiratory tract infection, pharyngitis, headache and rhinitis in patients treated with Symbicort 80/4.5 with a frequency of more than or equal to 3% and more often than patients treated with budesonide pMDI 80 mcg only. Symbicort is not indicated for the treatment of acute bronchospasm, nor does it replace fast-acting inhalers to treat acute symptoms.

“Symbicort is a cornerstone product in our growing respiratory franchise,” Gregory Keenan, MD, vice president and U.S. head medical officer for AstraZeneca and MedImmune, said in the press release. “We are pleased to now be able to offer this medicine to younger patients, helping to control and prevent asthma symptoms.”

Prior results demonstrate that Symbicort, an inhaled corticosteroid/long-acting beta2-agonist bronchodilator controller medication, can help control asthma by keeping airways open and reducing inflammation in the lungs. Now, with this expanded indication, the medication can be used to help a wider range of patients control their asthma, prevent coughing/wheezing and maintain good lung function. – by Savannah Demko

Disclosure: Keenan oversees all US Medical Affairs activities.