AstraZeneca (LSE:AZN) has received European Commission approval for Trixeo Aerosphere as a maintenance treatment for asthma in patients aged 12 years and older whose disease is inadequately controlled with standard dual inhaled therapy.
The approval makes Trixeo Aerosphere the first triple-combination inhaler therapy authorised in the European Union for this patient population.
The fixed-dose treatment combines an inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA) with a long-acting muscarinic antagonist.
Trixeo Aerosphere is marketed under the name Breztri in the US, China and Japan.
Phase III Trials Support EU Approval
The European approval was supported by results from the Phase III KALOS and LOGOS trials.
According to the trial data cited by AstraZeneca, the triple-combination treatment improved lung function, had a rapid onset of action and reduced the rate of severe asthma exacerbations compared with dual therapy.
The company also reported that no new safety signals were identified.
Nearly 43 million people in Europe have asthma, according to the information provided by AstraZeneca, and the new authorisation covers patients aged 12 and over whose condition remains inadequately controlled on dual inhaled treatment.
Trixeo Expands Beyond COPD
The European Commission decision extends the use of Trixeo Aerosphere into asthma. The treatment is already approved for chronic obstructive pulmonary disease, or COPD, in more than 90 countries.
The asthma authorisation provides AstraZeneca with an additional approved indication for the triple-combination inhaler within its Respiratory & Immunology portfolio.
AstraZeneca’s Respiratory Business
AstraZeneca is a global biopharmaceutical company headquartered in Cambridge, UK, focused on the discovery, development and commercialisation of prescription medicines.
The company’s operations include Oncology, Rare Disease and BioPharmaceuticals, encompassing Cardiovascular, Renal & Metabolism and Respiratory & Immunology.
Its respiratory portfolio includes inhaled therapies, biologics and other treatments targeting chronic respiratory and immune-mediated diseases.
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