BREZTRI Becomes First Triple Therapy Approved in the US for Asthma Patients Aged 12 and Older

Breztri is approved in the US for asthma as the first and only triple therapy for 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). It has also been approved in the US for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older.

Clinical Professor, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Njira Lugogo, MD, 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.

Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, Ruud Dobber stated, “As the fastest growing fixed-dose triple-combination therapy in COPD, BREZTRI is already improving outcomes for people suffering with COPD, and we are proud to extend its benefits to asthma patients. The FDA’s approval of BREZTRI in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases."

According to Towards Healthcare, the North America asthma and COPD drugs market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 17.13 billion in 2026 to approximately USD 25.68 billion by 2035, representing a compound annual growth rate (CAGR) of 4.6% from 2026 to 2035. Growth is driven by the increase in rates of asthma and Chronic Obstructive Pulmonary Disease (COPD), primarily driven by environmental factors, tobacco smoking, and an aging population, sustain a continuous demand for medication. With advanced biologics a rapid shift toward targeted therapies like Anti-IgE and Anti-IL monoclonal antibodies, which provide highly effective management for severe, uncontrolled forms of these respiratory conditions. 

Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, Ruud Dobber, said, “As the fastest growing fixed-dose triple-combination therapy in COPD, BREZTRI is already improving outcomes for people suffering from COPD, and we are proud to extend its benefits to asthma patients. The FDA’s approval of BREZTRI in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases.”

About BREZTRI

BREZTRI is a single-inhaler fixed-dose triple-combination therapy approved for the treatment of COPD in adults in 90 countries worldwide, including the US, EU, China, and Japan.

Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, Ruud Dobber, said, “As the fastest growing fixed-dose triple-combination therapy in COPD, BREZTRI is already improving outcomes for people suffering from COPD, and we are proud to extend its benefits to asthma patients. The FDA’s approval of BREZTRI in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases.”

A recent report by Towards Healthcare highlights that the North America asthma and COPD drugs market is witnessing growth driven by the growth opportunity and rising respiratory disease prevalence, robust healthcare infrastructure, and strong demand for innovative biologics, underlying inflammatory causes of both severe asthma and COPD.