The FDA has approved budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) as a maintenance treatment for patients with COPD, according to a press release from the manufacturer.
The approval follows the completion of two clinical trials, including the phase 3 ETHOS trial, which compared the triple-combination therapy of budesonide, glycopyrrolate, and formoterol fumarate with two different dual-therapies.
In the ETHOS trial, patients treated with the triple therapy had a 24% reduction (p<0.001) in exacerbations compared to the dual-therapy of glycopyrrolate/formoterol fumarate (Bevespi Aerosphere). Researchers also noted a 13% reduction (p=0.003) in exacerbations compared with PT009. The triple therapy also showed a 46% reduction in the risk of all-cause mortality compared with glycopyrrolate/formoterol fumarate (unadjusted p=0.01). Results of the trial were published in the New England Journal of Medicine and presented at the virtual scientific symposium of the American Thoracic Society.
“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease. Even a single exacerbation can have a negative impact on a patient’s lung function and quality of life, and it can increase the risk of death,” said Fernando J. Martinez, MD, MS, of Weill Cornell Medicine and New-York Presbyterian Weill Cornell Medical Center.
Adverse events were similar in all three treatment groups (range 61.7 to 64.5%), with confirmed cases of pneumonia ranging from 3.5 to 4.5% for patients receiving an inhaled glucocorticoid, and 2.3% in the glycopyrrolate-formoterol group.
The manufacturer’s release notes that Breztri Aerosphere has already been approved in Japan and China, with an application to the European Medicines Agency currently under review.