AstraZeneca (AZN) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Trixeo Aerosphere as a maintenance treatment for asthma patients aged 12 and older who remain uncontrolled on medium-dose inhaled corticosteroid and long-acting beta2-agonist therapy.

The positive opinion was based on Phase 3 KALOS and LOGOS trials, where Trixeo improved lung function and significantly reduced severe asthma exacerbations versus dual inhaled therapy in a pooled analysis.

If approved by the European Commission, asthma would become the second indication for Trixeo in Europe, where it is already approved for the treatment of chronic obstructive pulmonary disease, it added.