AstraZeneca said that complete results from the Phase 3 ETHOS trial of its Breztri Aerosphere (PT010) budesonide/glycopyrronium/formoterol fumarate MDI demonstrated that the triple combination reduced moderate or severe COPD exacerbations by 24% compared to glycopyrronium/formoterol fumarate and by 13% compared to budesonide/formoterol fumarate. Patients using Breztri Aerosphere also had a 46% reduced risk of all-cause mortality compared to patients using glycopyrronium/formoterol fumarate. The data were published in the New England Journal of Medicine and presented at a virtual ATS seminar.
The FDA issued a complete response letter to AstraZeneca’s NDA for PT010 in the fall of 2019; results from the Ethos trial had not been included in the submission. AZ said that an NDA is currently under review in the US, and a marketing application is also under review in the EU. Breztri Aerosphere is currently approved in China and Japan for the treatment of COPD.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Mene Pangalos commented, “Chronic obstructive pulmonary disease is the third leading cause of death worldwide and exacerbations can contribute to an increase in mortality in these patients. The results of the Phase 3 ETHOS trial support the strong clinical profile of Breztri Aerosphere in reducing exacerbation rates compared with dual-combination therapies. We are excited to have the data on all-cause mortality, which is a key consideration for COPD management.”
Read the AstraZeneca press release.
