BREZTRI is now available in the US as the first and only fixed-dose triple therapy for asthma patients 12 years of age and older

Building on a well-established profile in COPD, BREZTRI offers a new fixed-dose approach to triple therapy with the potential to advance care for the many asthma patients who remain symptomatic and at risk.

AstraZeneca's fixed-dose triple-combination therapy BREZTRI AEROSPHERE^®

(budesonide/glycopyrrolate/formoterol fumarate or BGF 160/18/4.8 μg) is now commercially available in the US by prescription for patient use. BREZTRI received FDA approval in April 2026 for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. BREZTRI is not used to relieve sudden breathing problems and will not replace a rescue inhaler.^1,2

BREZTRI is a three-in-one maintenance inhaler that combines a corticosteroid (ICS) and long-acting beta₂-agonist (LABA) medicines with a long-acting muscarinic antagonist (LAMA). BREZTRI was approved based on the results from two Phase III trials, KALOS and LOGOS, which studied a broad population of patients with asthma, with or without a recent asthma exacerbation.¹ In these trials, BREZTRI demonstrated significant lung function improvement compared with dual-combination inhaled ICS/LABA.¹

This approval marks a second indication for BREZTRI. BREZTRI (160/9/4.8 μg) 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.^3,4

Priya Bansal, MD, Physician and CEO, Asthma and Allergy Wellness Center and Clinical Assistant Professor, Northwestern Feinberg School of Medicine, said: "The burden of asthma can be debilitating, with symptoms varying patient by patient. BREZTRI's availability represents continued progress made for asthma care for both adolescents and adults, which not only helps patients manage their symptoms, but also can help alleviate the impact that asthma can have on their personal and professional lives. Now, by making another option available, patients can have greater choice as they seek treatment with their health care providers."

James Teague, Vice President, US Respiratory & Immunology and Vaccine & Immune Therapies, said: "We're thrilled to be able to offer BREZTRI to asthma patients in the US. This availability is the latest step in our commitment to providing transformative respiratory care, empowering patients to seek treatment options tailored to their unique asthma journeys. Patients interested in learning more about BREZTRI are encouraged to speak with their doctors to understand if BREZTRI is right for them."

Those interested in receiving BREZTRI should speak with a healthcare provider to determine if BREZTRI is an appropriate treatment option. AstraZeneca is offering a co-pay assistance program where eligible patients may pay as little as $0 for BREZTRI. To learn more, visit breztri.com.

IMPORTANT SAFETY INFORMATION

• BREZTRI combines 3 medicines, an inhaled corticosteroid (ICS) medicine (budesonide), an anticholinergic medicine (glycopyrrolate), and a long-acting beta₂-adrenergic agonist (LABA) medicine (formoterol fumarate). LABA medicines, such as formoterol fumarate, when used alone can increase the risk of hospitalizations and death from asthma problems. When an ICS and LABA are used together, this risk is not significantly increased

• Do not use BREZTRI to treat sudden severe symptoms of COPD or asthma, or if you are allergic to budesonide, glycopyrrolate, formoterol fumarate, or any of the ingredients in BREZTRI

• Do not take BREZTRI with other medicines that contain a long-acting beta₂-adrenergic agonist (LABA) or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take

• Do not use BREZTRI more than prescribed

• Do not use in children younger than 12 years of age

• Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need to use your rescue inhaler more often than usual, or your rescue inhaler does not work as well to relieve your symptoms

• BREZTRI can cause serious side effects, including:
  • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREZTRI to help reduce your chance of getting thrush
  • Pneumonia. People with COPD have a higher chance of getting pneumonia. Call your healthcare provider if you notice an increase in mucus (sputum) production or change in mucus color, fever, chills, increased cough, or increased breathing problems
  • Weakened immune system and increased chance of getting infections (immunosuppression)
  • Reduced adrenal function (adrenal insufficiency). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine
  • Sudden breathing problems immediately after inhaling BREZTRI. If this happens, stop taking BREZTRI and call your healthcare provider right away
  • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms: rash; hives; swelling of your face, mouth, and tongue; or breathing problems
  • Effects on your heart such as increased blood pressure, a fast or irregular heartbeat, or chest pain
  • Effects on your nervous system such as tremor or nervousness
  • Bone thinning or weakness (osteoporosis)
  • Slowed growth in children. A child's growth should be checked regularly while using BREZTRI
  • Acute narrow-angle glaucoma and cataracts. If you have new or worsening eye or vision problems, call your healthcare provider right away before taking another dose
  • Urinary retention. If you have new or worsening symptoms or difficulty urinating, stop taking BREZTRI and call your healthcare provider right away before taking another dose
  • Changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia). Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm

• Most common side effects include: upper respiratory tract infection, pneumonia, back pain, thrush in your mouth and throat, joint pain, flu, headache, high blood sugar levels, muscle spasms, cough, inflammation of the sinuses, diarrhea, hoarseness, urinary tract infection, nausea, difficulty sleeping, feeling anxious and heart palpitations

APPROVED USE

BREZTRI AEROSPHERE 160/9/4.8 mcg is used long term to treat chronic obstructive pulmonary disease (COPD) in adults, including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.

BREZTRI AEROSPHERE 160/18/4.8 mcg is used for the treatment of asthma in patients 12 years of age and older.

BREZTRI is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

Please see full Prescribing Information, including Patient Information and Instructions for Use, and discuss with your doctor.

You may report side effects related to AstraZeneca products (Opens new window).

Notes

Asthma

Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide,⁵ including 27 million in the US.⁶ When uncontrolled, inflammation and muscle tightening in the airway (bronchoconstriction) may cause wheezing, breathlessness, chest tightness, coughing, and even death.^7,8,9 Many patients remain uncontrolled despite the availability of standard of care medicines and continue to experience significant limitations on lung function and reduced quality of life.^7,8,9

KALOS and LOGOS Phase III trials
KALOS and LOGOS were replicate confirmatory, randomized, double-blind, double-dummy, parallel-group, multi-center, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of BREZTRI AEROSPHERE compared with SYMBICORT^® (budesonide/formoterol fumarate dihydrate), a marketed therapeutic option, and PT009 (budesonide/formoterol fumarate dihydrate) in an AEROSPHERE formulation.¹ Together, KALOS and LOGOS comprise the largest Phase III clinical program evaluating a fixed-dose triple therapy in asthma, enrolling a broad population of over 4,300 adult and adolescent patients, with or without a recent exacerbation.^1,10,11

The primary endpoints and treatment comparisons in the KALOS and LOGOS trials differed according to regulatory submission approaches. In the data package submitted to the US FDA, the primary lung function endpoint was change from baseline in FEV₁ AUC_0-3 at Week 24, and the key secondary endpoint was change from baseline in morning pre-dose trough FEV₁ at Week 24, compared to PT009.¹

BREZTRI AEROSPHERE

Budesonide/glycopyrronium/formoterol fumarate or budesonide/glycopyrrolate/formoterol fumarate, is approved under the brand name BREZTRI AEROSPHERE in Japan, China and the US, and TRIXEO AEROSPHERE in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an ICS, and delivered via the AEROSPHERE pMDI. BREZTRI/TRIXEO AEROSPHERE is approved to treat adults with COPD in 90 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 6.8 million patients globally in 2025.⁴

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca.

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References

1. Papi A, et al. Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials. Lancet Respir Med. 2026;14(4):350-362.
2. AstraZeneca. Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older. Accessed July 13, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/breztri-approved-in-the-us-for-asthma.html.
3. AstraZeneca. Breztri Aerosphere approved in the US for the maintenance treatment of COPD. Accessed July 13, 2026. https://www.astrazeneca.com/media-centre/press-releases/2020/breztri-aerosphere-approved-in-the-us-for-copd.html.
4. Data on File. REF-325003. AstraZeneca Pharmaceuticals LP.
5. Global Asthma Network. The Global Asthma Report 2022. Accessed July 13, 2026. https://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf.
6. Centers for Disease Control and Prevention. Most Recent Asthma Data. Accessed July 13, 2026. https://www.cdc.gov/asthma-data/about/most-recent-asthma-data.html
7. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014;40(4):364-372.
8. Davis J, et al. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma. 2019;56(3):332-340.
9. Buhl R, et al. One-year follow up of asthmatic patients newly initiated on treatment with medium- or high-dose inhaled corticosteroid-long-acting β₂-agonist in UK primary care settings. Respir Med. 2020;162:105859.
10. ClinicalTrials.gov. Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS). Accessed July 13, 2026. https://clinicaltrials.gov/study/NCT04609878?limit=25&term=KALOS&rank=1.
11. ClinicalTrials.gov. Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS). Accessed July 13, 2026. https://clinicaltrials.gov/study/NCT04609904?limit=25&term=LOGOS&rank=4.