BREZTRI approved in the US for asthma as first and only triple therapy for patients 12 years of age and older

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[{"type":"text","content":"Approval based on KALOS and LOGOS Phase III trials demonstrating statistically significant and clinically meaningful benefits of AstraZeneca’s single-inhaler fixed-dose triple therapy compared with inhaled dual therapy","length":218,"tagName":"p","attribs":{}},{"type":"text","content":"Approval is second indication for BREZTRI beyond COPD","length":53,"tagName":"p","attribs":{}},{"type":"text","content":"WILMINGTON, Del., April 28, 2026--(BUSINESS WIRE)--AstraZeneca’s fixed-dose triple-combination therapy BREZTRI Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. BREZTRI is a single-inhaler that combines the efficacy of corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines with a long-acting muscarinic antagonist (LAMA). BREZTRI (320/18/9.6μg) was approved in the US in 2020 to treat adults with chronic obstructive pulmonary disease (COPD) and was prescribed to more than 6.8 million patients globally in 2025.1,2","length":680,"tagName":"p"},{"type":"text","content":"The approval by the US Food and Drug Administration (FDA) was based on efficacy and safety data from the Phase III KALOS and LOGOS trials investigating BREZTRI in a broad population consisting of patients with asthma, with or without a recent asthma exacerbation.3 In these trials, BREZTRI demonstrated a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled ICS/LABA.3 In a key secondary endpoint, BREZTRI also demonstrated a rapid onset of action with a significant improvement from baseline in lung function within five minutes after the first dose.3 BREZTRI is a maintenance therapy and is not used to relieve sudden breathing problems and will not replace a rescue inhaler.","length":744,"tagName":"p"},{"type":"text","content":"Njira Lugogo, MD, Clinical Professor, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, said: "Despite the availability of dual maintenance therapy, many patients are still at risk for exacerbations and experience daily breathing difficulties, reduced lung function and the ongoing fear of worsening symptoms. The FDA approval of BREZTRI as the only maintenance tr...

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