AstraZeneca advanced its respiratory portfolio on Tuesday following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending Trixeo Aerosphere for asthma treatment. The recommendation brings the inhaler closer to formal European Commission approval.

The CHMP's positive opinion was supported by data from the KALOS and LOGOS Phase III trials, which assessed the fixed triple combination of formoterol, glycopyrronium and budesonide in adults with inadequately controlled asthma. AstraZeneca said the trials met their primary endpoints on lung function and exacerbation reduction.

Trixeo Aerosphere is already approved in the European Union as a maintenance treatment for chronic obstructive pulmonary disease. An expanded asthma indication would allow physicians to prescribe a single triple-therapy inhaler to a broader group of patients whose symptoms remain uncontrolled on existing dual therapies.

An AstraZeneca spokesperson said the company expected a final decision from the European Commission in the coming months and would work with national health authorities on reimbursement and availability. The CHMP opinion typically precedes Commission approval by roughly two months.

Respiratory disease remains a core commercial priority for AstraZeneca, which competes with GSK and Chiesi in the inhaled-therapy market. Analysts have said an asthma indication could meaningfully broaden the drug's addressable patient population across Europe.