Astrazeneca PLC Sponsored ADR (AZN.US) Triple therapy for asthma approved for market launch.

On April 28th, Astrazeneca PLC Sponsored ADR (AZN.US) announced that Bevespi Aerosphere inhalation aerosol (320/36/9.6 g) has been approved by the FDA for maintenance treatment of asthma patients aged 12 and above. Bevespi is a fixed dose triple therapy developed by Astrazeneca PLC Sponsored ADR, containing the active ingredients budesonide (corticosteroid), glycopyrrolate (long-acting muscarinic antagonist), and formoterol (long-acting beta2-adrenergic agonist). This approval by the FDA was based on positive results from two Phase III studies (KALOS and LOGOS). These studies enrolled a total of 4461 poorly controlled adult and adolescent asthma patients and evaluated the efficacy and safety of Bevespi Aerosphere inhalation aerosol compared to the dual therapy Symbicort (budesonide + formoterol) as maintenance treatment. The results showed that compared to the Symbicort group, patients in the Bevespi Aerosphere inhalation aerosol group had significant improvements in forced expiratory volume in 1 second (FEV1) and a significant reduction in the rate of severe asthma exacerbations.