AstraZeneca gets EU nod for Trixeo Aerosphere to treat COPD
COPD is a progressive disease, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness and is the third leading cause of death globally.;
UK: AstraZeneca has recently announced that Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been approved in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist (LAMA).
The approval by the European Commission was based on positive results from the ETHOS Phase III trial in which Trixeo 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 (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) over 52 weeks. The approval was also supported by efficacy and safety data from the KRONOS Phase III trial.
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