AstraZeneca's Triple Therapy for Asthma Receives Regulatory Clearance

Stock News
Apr 29

On April 28, AstraZeneca PLC announced that its Budesonide/Glycopyrronium/Formoterol Fumarate Inhalation Aerosol (320/36/9.6µg, brand name: Breztri Aerosphere®) has received approval from the FDA for the maintenance treatment of asthma in patients aged 12 and above. The product is a fixed-dose triple therapy developed by AstraZeneca, containing three active pharmaceutical ingredients: budesonide (a corticosteroid), glycopyrronium (a long-acting muscarinic antagonist), and formoterol fumarate (a long-acting beta2-adrenergic agonist). The FDA approval was based on positive results from two Phase III studies, KALOS and LOGOS. These studies enrolled a total of 4,461 adult and adolescent patients with inadequately controlled asthma, evaluating the efficacy and safety of Breztri Aerosphere® compared to the dual therapy Symbicort® (budesonide + formoterol) as a maintenance treatment. Results demonstrated that patients in the Breztri Aerosphere® group showed a significant improvement in forced expiratory volume in one second (FEV1) and a significant reduction in the rate of severe asthma exacerbations compared to the Symbicort® group.

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