FDA approves label changes on inhaled corticosteroid/LABA medications

The FDA has approved changing the boxed labeling on inhaled corticosteroid/long-acting beta₂ antagonist combination medications manufactured by GlaxoSmithKline upon review of four randomized controlled safety trials in children aged 4 to 11 years, as well as adolescents and adults.

Additionally, the FDA has also approved the updates to the Warning and Precautions section of labeling for these drugs, which include Breo Ellipta (fluticasone furoate/vilanterol, GlaxoSmithKline [GSK]), Advair Diskus (fluticasone propionate/salmeterol, GSK) and Advair HFA. All updates were approved on Dec. 20.

According to a press release issued by GSK, the studies were in response to a Post-Marketing Requirement issued by the FDA in 2010 that required manufacturers of long-acting beta₂ antagonist–containing medications for asthma treatment to conduct large-scale studies of their safety in combination with inhaled corticosteroid treatment in adolescents and adults. Children aged between 4 and 11 years had been approved to use fluticasone propionate/salmeterol, which led GSK to conduct a second, separate study.

The two of the studies included for review — AUSTRI and VESTRI — compared the combination of medications within the Advair Diskus with fluticasone propionate. No additional risks were observed when used in children aged between 4 and 11 years or adolescents and adults.

The VESTRI study highlighted the use of inhaled corticosteroids for pediatric asthma through a global, multicenter, randomized stratified, double-blind, parallel-group. active-comparator 6-month study. All children included in the study went through a review of previous asthma medications, asthma control and an exacerbation within the previous year which required treatment with a systemic corticosteroid.

When eligibility was met, they were randomized 1:1 to receive either the medications within Advair Diskus at 100/50 or 250/50 mcg doses or fluticasone propionate at 100 or 250 mcg doses. If needed, children were able to use albuterol/salbutamol rescue medication.

The AUSTRI study included asthmatic adolescents aged between 12 and 17 years, as well as adults aged 18 years and older with asthma. This global, multicenter, randomized stratified, double-blind, parallel-group, active-comparator 26-week study. Inclusion criteria involved a history of asthma for a minimum of 1 year before randomization and one severe exacerbation that warranted treatment with oral corticosteroids or asthma-related hospitalization within the year but not within 30 days before randomization.

Like the VESTRI study, participants within the AUSTRI study were administered 100 or 250 mcg of fluticasone propionate or the medications within the Advair Diskus. These patients also were allowed to use albuterol/salbutamol rescue medication during the study, if needed.

The results of both studies have been published in the New England Journal of Medicine and are available on the GSK Clinical Study Register. – by Katherine Bortz