LONDON (dpa-AFX) - AstraZeneca PLC (AZN) Wednesday said the European Commission has approved Trixeo Aerosphere as a maintenance treatment for asthma in patients aged 12 and older who are not adequately controlled with medium-dose inhaled corticosteroid and long-acting beta2-agonist therapy.
Trixeo Aerosphere, marketed as Breztri Aerosphere in the US, China and Japan, is a triple-combination therapy containing three active ingredients: budesonide, an inhaled corticosteroid; glycopyrronium, a long-acting muscarinic antagonist; and formoterol fumarate, a long-acting beta2-agonist.
The approval is based on positive results from the Phase III KALOS and LOGOS trials, which showed statistically significant improvements in lung function compared with inhaled corticosteroid/long-acting beta2-agonist treatments.
Additionally, in a pooled analysis of KALOS and LOGOS, Trixeo significantly reduced the annual rate of severe asthma exacerbations.
Trixeo/Breztri is already approved in the US and Japan for asthma treatment and is under review in China and other countries. It is also approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults in 90 countries, including the US, EU, China and Japan.
On the NYSE, AstraZeneca shares closed nearly flat at $168.37 on Tuesday.
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