FDA Approves Budesonide/Glycopyrrolate/Formoterol Fumarate for Treatment of Patients With COPD

Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere, AstraZeneca) has been approved by the FDA for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), according to a press release.

The approval is based on positive results from the phase 3 ETHOS trial, in which the triple combination therapy showed a significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies glycopyrrolate/formoterol fumarate and budesonide/formoterol fumarate (PT009). In addition, the approval was supported by efficacy and safety data from the phase 3 KRONOS trial.

“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease,” said Fernando J. Martinez, MD, investigator of the ETHOS trial, in a press release. “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. Breztri Aerosphere has demonstrated significant benefits in reducing exacerbations in patients suffering from COPD.”

The most common adverse reactions found in the 52-week trial included upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infection, cough, sinusitis, and diarrhea. In the 24-week trial, adverse reactions were dysphonia and muscle spasms.

REFERENCE

Breztri Aerosphere approved in the US for the maintenance treatment of COPD. AstraZeneca. https://www.astrazeneca-us.com/media/press-releases/2020/breztri-aerosphere-approved-in-the-us-for-the-maintenance-treatment-of-copd-07242020.html. Published July 24, 2020. Accessed July 24, 2020.