Breztri Aerosphere approved as maintenance COPD treatment in USA

24 July 2020

Anglo-Swedish pharma major AstraZeneca (LSE: AZN) has announced the approval of Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) in the USA for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

The approval by the US Food and Drug Administration (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).

Efficacy and safety data from the Phase III KRONOS trial also supported the approval.

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