Posted by Michael Wonder on 25 Jul 2020
Breztri Aerosphere approved in the US for the maintenance treatment of COPD
24 July 2020 - Approval based on Phase III ETHOS trial which showed a statistically significant reduction in the rate of exacerbations compared with dual-combination therapies.
AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease.
The approval by the US FDA was based on positive results from the Phase III ETHOS trial in which Breztri Aerosphere, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). The approval was also supported by efficacy and safety data from the Phase III KRONOS trial.
