FDA approves Breztri for asthma: First triple-combination inhaler for patients 12 years and older

The US Food and Drug Administration (FDA) has approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of asthma in patients 12 years and older, making it the first and only single-inhaler, fixed-dose, triple-combination therapy available for this indication. The approval, announced April 28, 2026, represents the drug’s second US indication following its 2020 approval for chronic obstructive pulmonary disease (COPD) in adults.¹

“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,” said Njira Lugogo, MD, clinical professor in the Division of Pulmonary and Critical Care Medicine at the University of Michigan. “The FDA approval of Breztri as the only maintenance triple therapy for people with asthma 12 years of age and older marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner.”

Trial design and key findings

The approval was based on data from the KALOS and LOGOS phase 3 trials, replicate randomized, double-blind, double-dummy, parallel-group, multicenter studies of variable length (24 to 52 weeks) enrolling approximately 4300 patients with inadequately controlled asthma with or without a recent exacerbation history.² The trials compared Breztri to dual-combination inhaled corticosteroid/long-acting beta₂-agonist (ICS/LABA) therapies, including both the marketed formulation of budesonide/formoterol (Symbicort) and a developmental Aerosphere formulation (PT009).

The primary lung function end point submitted to the FDA was change from baseline in forced expiratory volume in 1 second (FEV₁) area under the curve from 0 to 3 hours (AUC₀₋₃) at week 24, compared with PT009. Breztri demonstrated statistically significant and clinically meaningful improvements on this measure. A key secondary end point showed significant improvement from baseline in morning pre-dose trough FEV₁ at week 24. Notably, a rapid onset of action was observed, with significant lung function improvement within 5 minutes of the first dose.² No new safety or tolerability signals were identified. The most common adverse reactions (incidence, ≥2%) in asthma trials were nasopharyngitis, pneumonia, and headache.

Unmet need in asthma management

Approximately 27 million people in the United States live with asthma, and nearly 10 million asthma attacks occur annually.³ Despite the availability of ICS/LABA dual maintenance therapies, an estimated half of patients remain inadequately controlled, continuing to experience bronchoconstriction, exacerbations, and reduced quality of life. The addition of a long-acting muscarinic antagonist (LAMA) to ICS/LABA therapy has been explored as a step-up strategy in guidelines, but until this approval, no single-inhaler, triple-combination product had been specifically indicated for asthma in the US.

Mechanism and drug background

Breztri Aerosphere combines 3 active agents in a pressurized metered-dose inhaler: budesonide (an ICS that reduces airway inflammation), glycopyrrolate (a LAMA that reduces bronchoconstriction via muscarinic receptor blockade), and formoterol fumarate (a LABA that provides bronchodilation). The triple-combination approach targets complementary pathways underlying airway obstruction. The product was first approved in the US in July 2020 for COPD maintenance therapy and has since been approved in 90 countries worldwide for COPD.¹

Interpretive considerations

Although the KALOS and LOGOS data support lung function improvements with triple therapy over dual ICS/LABA, clinicians should note that the primary end point was a spirometric measure (FEV₁ AUC₀₋₃) rather than annualized exacerbation rate reduction. The trial results were published in The Lancet Respiratory Medicine in February 2026, and a full evaluation of exacerbation outcomes and long-term safety in adolescent populations will be important for guiding clinical decision-making.² Regulatory filings for this indication are under review in the EU, Japan, and China. Breztri is a maintenance therapy and is not indicated for the relief of acute bronchospasm; it should not replace a rescue inhaler.⁴

KEY FACTS

• Drug: Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate)
• Class: ICS/LAMA/LABA triple combination
• New indication: Asthma maintenance, age ≥12 y
• Trials: KALOS and LOGOS (phase 3)
• Primary end point: FEV₁ AUC₀₋₃ at week 24
• Onset: Significant FEV₁ gain within 5 min
• Safety: No new signals; adverse effects include nasopharyngitis, pneumonia, headache
• Regulatory status: FDA approved (US); under review in EU, Japan, China

References

1. Breztri Aerosphere approved in the US for the maintenance treatment of COPD. News release. AstraZeneca. July 24, 2020. Accessed April 2026. https://www.astrazeneca.com/media-centre/press-releases/2020/breztri-aerosphere-approved-in-the-us-for-copd.html
2. Papi A, Wise RA, Jackson DJ, et al. Budesonide/glycopyrronium/formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin phase 3, randomised, double-blind, double-dummy, parallel-group, multicentre trials. Lancet Respir Med. 2026;14(4):350-362. doi:10.1016/S2213-2600(25)00457-6
3. Most recent asthma data. CDC. November 21, 2024. Accessed April 28, 2026. https://www.cdc.gov/asthma-data/about/most-recent-asthma-data.html
4. Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older. News release. AstraZeneca. Accessed April 28, 2026. https://www.businesswire.com/news/home/20260428568372/en/BREZTRI-approved-in-the-US-for-asthma-as-first-and-only-triple-therapy-for-patients-12-years-of-age-and-older