Budesonide/Formoterol Fumarate Dihydrate

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 Approval is second indication for BREZTRI beyond COPD WILMINGTON, Del.--(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 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. 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 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.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “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.” There are 27 million people living with asthma in the US, 4 around half of whom continue to be uncontrolled on dual therapies, leading to inflammation and muscle tightening in the airway (bronchoconstriction) that cause wheezing, breathlessness, chest tightness, coughing exacerbations and even death. 5,6 Nearly 10 million asthma attacks still occur each year in the US. 4 Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026. 3 There were no new safety or tolerability signals identified for BREZTRI in the trials. 3 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. Regulatory filings for BREZTRI in asthma are currently under review in other major regions including the EU, Japan and China. IMPORTANT SAFETY INFORMATION BREZTRI is contraindicated: For the primary treatment of status asthmaticus or other acute episodes of asthma or COPD requiring intensive measures In patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate or product excipients Long-acting beta 2 -adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of serious asthma-related events. These findings are considered a class effect of LABA monotherapy. When a LABA is used in a fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS use alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD BREZTRI should not be initiated in patients with acutely deteriorating COPD or asthma, which may be a life-threatening condition BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute symptoms; treat with an inhaled short-acting beta 2 -agonist BREZTRI should not be used more often than recommended; at higher doses than recommended; or in combination with LABA-containing medicines, due to risk of overdose. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing budesonide. Advise patients to rinse their mouths with water without swallowing after inhalation Lower respiratory tract infections, including pneumonia, have been reported following ICS. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap Due to possible immunosuppression, potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREZTRI Hypercorticism and adrenal suppression may occur with regular or very high dosage in susceptible individuals. If such changes occur, consider appropriate therapy Caution should be exercised when considering the coadministration of BREZTRI with long-term ketoconazole and other known strong CYP3A4 Inhibitors. Adverse effects related to increased systemic exposure to budesonide may occur If paradoxical bronchospasm occurs, discontinue BREZTRI immediately and institute alternative therapy Anaphylaxis and other hypersensitivity reactions (eg, angioedema, urticaria or rash) have been reported. Discontinue and consider alternative therapy Use caution in patients with cardiovascular disorders, especially coronary insufficiency, as formoterol fumarate can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles Decreases in bone mineral density have been observed with long-term administration of ICS. Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content Monitor growth in pediatric patients Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur, so use with caution. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term. Instruct patients to contact a healthcare provider immediately if symptoms occur Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if symptoms occur Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually responsive to sympathomimetic amines Be alert to hypokalemia or hyperglycemia Most common adverse reactions (incidence ≥ 2%) are: COPD: upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infection, cough, sinusitis, and diarrhea Asthma: nasopharyngitis, pneumonia, and headache BREZTRI should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors and tricyclic antidepressants, as these may potentiate the effect of formoterol fumarate on the cardiovascular system BREZTRI should be administered with caution to patients being treated with: Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects) Adrenergic drugs (may potentiate effects of formoterol fumarate) Xanthine derivatives, steroids, or non-potassium sparing diuretics (may potentiate hypokalemia and/or ECG changes) Beta-blockers (may block bronchodilatory effects of beta-agonists and produce severe bronchospasm) Anticholinergic-containing drugs (may interact additively). Avoid use with BREZTRI Use BREZTRI with caution in patients with hepatic impairment, as budesonide and formoterol fumarate systemic exposure may increase. Patients with severe hepatic disease should be closely monitored INDICATIONS BREZTRI AEROSPHERE 160 mcg/9 mcg/4.8 mcg is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. BREZTRI AEROSPHERE 160 mcg/18 mcg/4.8 mcg is indicated for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. LIMITATIONS OF USE Not indicated for the relief of acute bronchospasm. Please see full BREZTRI Prescribing Information , including Patient Information . You may report side effects related to AstraZeneca products . Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide, 8 including 27 million in the US. 4 When uncontrolled, inflammation and muscle tightening in the airway (bronchoconstriction) may cause wheezing, breathlessness, chest tightness, coughing, and even death. 5-7 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. 6,7 KALOS and LOGOS Phase III trials KALOS and LOGOS were replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of BREZTRI Aerosphere compared with S ymbicort (budesonide/formoterol fumarate, a marketed therapeutic option), PT009 (budesonide/formoterol fumarate in an Aerosphere formulation) and the Symbicort and PT009 treatment groups combined. 3,9,10 KALOS and LOGOS included approximately 4,300 randomised patients. The primary endpoints for the two individual trials were a change from baseline in forced expiratory volume in 1 second (FEV 1 ) area under the curve 0 to 3 hours (AUC 0-3 ) at Week 24 and trough FEV 1 over 12-24 weeks and over 24 weeks. 3,9,10 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 FEV 1 AUC 0-3 at week 24, and the key secondary endpoint was change from baseline in morning pre-dose trough FEV 1 at week 24, compared to PT009. 3 BREZTRI / TRIXEO 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. 2 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 commercialisation 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 . References AstraZeneca. Breztri Aerosphere approved in the US for the maintenance treatment of COPD. Press Release. 24 July 2020. Available at: . [Last accessed: April 2026]. AstraZeneca. Data On File. REF-325003. Papi A, 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. Available at: (25)00457-6/abstract [Last accessed: April 2026]. U.S. Centers for Disease Control and Prevention (CDC). Most Recent Asthma Data. [Online]. Available at: [Last accessed: April 2026]. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol . 2014; 40 (4): 364-372. Davis J, et al. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma . 2019 Mar;56(3):332-340. 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 Feb: 162:105859. Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: . [Last accessed: April 2026]. Clinicaltrials.gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) [Online]. Available at: . [Last accessed: April 2026]. Clinicaltrials.gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS) [Online]. Available at: [Last accessed: April 2026]. Contacts Media Inquiries Fiona Cookson +1 212 814 3923 US Media Mailbox: usmediateam@astrazeneca.com

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 Approval is second indication for Breztri beyond COPD 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 paediatric 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 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. 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 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.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “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.” There are 27 million people living with asthma in the US,4 around half of whom continue to be uncontrolled on dual therapies, leading to inflammation and muscle tightening in the airway (bronchoconstriction) that cause wheezing, breathlessness, chest tightness, coughing exacerbations and even death.5-7 Nearly 10 million asthma attacks still occur each year in the US.4 Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.3 There were no new safety or tolerability signals identified for Breztri in the trials.3 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. Regulatory filings for Breztri in asthma are currently under review in other major regions including the EU, Japan and China. Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide,8 including 27 million in the US.4 When uncontrolled, inflammation and muscle tightening in the airway (bronchoconstriction) may cause wheezing, breathlessness, chest tightness, coughing, and even death.5-7 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.6,7 KALOS and LOGOS Phase III trials KALOS and LOGOS were replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of Breztri Aerosphere compared with Symbicort (budesonide/formoterol fumarate, a marketed therapeutic option), PT009 (budesonide/formoterol fumarate in an Aerosphere formulation) and the Symbicort and PT009 treatment groups combined.3,9,10 KALOS and LOGOS included approximately 4,300 randomised patients. The primary endpoints for the two individual trials were a change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 and trough FEV1 over 12-24 weeks and over 24 weeks.3,9,10 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 AUC0-3 at week 24, and the key secondary endpoint was change from baseline in morning pre-dose trough FEV1 at week 24, compared to PT009.3 Breztri/Trixeo 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 2025.2 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 commercialisation 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. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Matthew Bowden Company Secretary AstraZeneca PLC tags Corporate and financial