AstraZeneca to showcase latest research on comprehensive portfolio and pipeline aimed at transforming respiratory diseases at ATS 2025

New data for AIRSUPRA and BREZTRI highlight progress in advancing asthma and COPD care globally

AstraZeneca will present the latest clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the American Thoracic Society (ATS) International Conference, in San Francisco, CA from May 16 to 21, 2025.

With more than 75 abstracts, including eight late-breakers, the Company continues to drive innovation and address unmet needs in care across all severities of asthma, chronic obstructive pulmonary disease (COPD), eosinophilic granulomatosis with polyangiitis (EGPA) and other chronic inflammatory diseases.

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “With asthma and COPD affecting hundreds of millions of people – and COPD now the third leading cause of death worldwide – our portfolio of inhaled and biologic medicines is central to achieving our bold ambition to transform respiratory care. The data we’re presenting at ATS focus on important gaps in care today, including improving the treatment approach to asthma rescue medication, reducing cardiopulmonary risk in COPD and targeting the underlying mechanisms that drive a broad range of inflammatory diseases."

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Today, far too many patients with asthma remain uncontrolled in their disease. Our data at ATS demonstrate progress we’ve made in advancing innovative treatments, moving beyond symptom control into disease modification, remission and one day, potentially a cure. We’re particularly excited by the results of the BATURA Phase IIIb trial exploring AIRSUPRA and its potential to transform rescue treatment in asthma, and look forward to discussing the full data with the scientific community."

Through data from our inhaled portfolio, we are advancing the science in asthma and COPD for patients who remain uncontrolled on current treatments:

• AIRSUPRA^® (albuterol/budesonide): Anti-inflammatory rescue treatment demonstrates potential to be the preferred rescue across all asthma severities, superior to albuterol-alone, according to guidelines outlined by Global Initiative for Asthma (GINA)

• BATURA Phase IIIb prespecified analysis: data explores the impact of as-needed AIRSUPRA compared with albuterol-alone in reducing cumulative exposure to systemic corticosteroids in people with mild asthma.¹
• MANDALA Phase III study post-hoc analysis: this analysis explores time-to-first severe exacerbation and annualized exacerbation rate in the first 3 months post-treatment initiation with as-needed AIRSUPRA versus albuterol-alone.²
• GRANITE study baseline characteristics: clinical characteristics of early users of AIRSUPRA in a US claims database.³

• BREZTRI ^® (budesonide/glycopyrrolate/formoterol fumarate, BGF): Enhancing our understanding of the impact on cardiopulmonary outcomes and the COPD-asthma connection with BREZTRI, an inhaled triple therapy

• ETHOS Phase III post-hoc analysis: the new analysis explores the estimated number needed to treat (NNT) across a range of cardiopulmonary endpoints with BREZTRI compared to dual long-acting muscarinic antagonists (LAMA)/long-acting beta-agonists (LABAs) therapy in patients with moderate-to-very severe COPD.⁴
• MITOS EROS+CP studies: late-breaking real-world data investigates whether prompt initiation of BREZTRI after a COPD exacerbation is associated with reduced subsequent COPD exacerbations and cardiopulmonary events in patients with COPD compared to delayed and very-delayed initiation strategies. Data also investigates impact of BREZTRI on COPD exacerbations in patients with COPD and asthma compared to delayed and very-delayed initiation strategies.^5,6
• Functional respiratory imaging (FRI) study: the first of its kind study to assess the lung deposition profile of BREZTRI in patients with COPD and concomitant asthma (ACO) who have persistent airflow limitation.⁷

Highlights from data across our leading biologics portfolio demonstrate efforts to target the underlying mechanisms that drive a broader range of inflammatory conditions:

• FASENRA^® (benralizumab): Demonstrating FASENRA's unique mechanism of action targeting and removing the source of eosinophilic inflammation across diseases

• MANDARA open label extension: two-year efficacy and safety data for the treatment of EGPA will explore remission rates with switch from mepolizumab to FASENRA and impact on oral corticosteroid (OCS) sparing.⁸
• FASENRA and depemokimab modeling comparison: results will highlight eosinophil depletion with FASENRA versus depemokimab through pharmacokinetic/pharmacodynamic (PK/PD) model simulation.⁹
• ZEPHYR-5 study: in patients with a diagnosis of asthma and concomitant COPD, a retrospective US database analysis will demonstrate the impact FASENRA has on the rate of COPD exacerbations.¹⁰

• TEZSPIRE^® (tezepelumab): Advancing the science of TEZSPIRE’s unique mechanism of action targeting thymic stromal lymphopoietin (TSLP) as a key driver in a range of epithelial-driven inflammatory diseases

• WAYFINDER Phase IIIb study: data will evaluate the impact of TEZSPIRE on OCS use in OCS-dependent patients with severe asthma.¹¹

• WAYPOINT sub-analysis: efficacy and safety data will evaluate effects of TEZSPIRE in adults with severe chronic rhinosinusitis with nasal polyps, with and without co-morbid asthma.¹²
• COURSE Phase IIa trial: a proof-of-concept trial investigating TEZSPIRE in moderate to very severe COPD patients irrespective of inflammatory drivers, baseline blood eosinophil levels, emphysema, chronic bronchitis and smoking status.¹³

• Tozorakimab: Demonstrating potential benefits of tozorakimab to reduce excess inflammation in IL-33 driven diseases

• FRONTIER Phase II program: results from four studies across asthma and COPD explore tozorakimab’s safety profile.¹⁴
• Retrospective cohort study on COPD exacerbations and smoking status: characteristics and outcomes of people with COPD who experience frequent/severe exacerbations while receiving inhaled triple therapy were evaluated based on their smoking status.¹⁵
• Retrospective cohort study on treatment patterns in US patients hospitalized for severe viral lower respiratory tract disease (LRTD): data will provide new insight into medication use in patients with severe viral LRTD, stratified by time period, viral etiology and clinical severity.¹⁶

• Data on our early-stage pipeline and machine learning (AI) showcase how we are deepening our understanding of new diseases through technology and exploring new pathways in COPD:

• GREAT-2 Phase II trial: efficacy and safety data will evaluate effects of gremubamab (MEDI3902) in patients with bronchiectasis and Pseudomonas aeruginosa colonization, which is associated with increased exacerbations and poor outcomes in bronchiectasis.¹⁷
• COPD pre-clinical data: data evaluates the impact of AZD6793, a novel IRAK4 inhibitor currently undergoing clinical investigation, on multiple disease-relevant pathways in COPD.^18-20
• Deep learning-based studies: data explore how we are utilizing machine learning to predict disease progression, advancing our understanding of respiratory diseases with significant unmet medical need, including idiopathic pulmonary fibrosis (IPF)^21-23 and COPD.²⁴

Key AstraZeneca presentations during ATS 2025:

INDICATIONS AND LIMITATIONS OF USE / ISI

AIRSUPRA^® (albuterol and budesonide)

• Contraindications: Hypersensitivity to albuterol, budesonide, or to any of the excipients
• Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient continues to experience symptoms after using AIRSUPRA or requires more doses of AIRSUPRA than usual, it may be a marker of destabilization of asthma and requires evaluation of the patient and their treatment regimen
• Paradoxical Bronchospasm: AIRSUPRA can produce paradoxical bronchospasm, which may be life threatening. Discontinue AIRSUPRA immediately and institute alternative therapy if paradoxical bronchospasm occurs. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister
• Cardiovascular Effects: AIRSUPRA, like other drugs containing beta₂-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by pulse rate, blood pressure, and/or other symptoms. If such effects occur, AIRSUPRA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST-segment depression. Therefore, AIRSUPRA, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
• Do Not Exceed Recommended Dose: Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs
• Hypersensitivity Reactions, Including Anaphylaxis: Can occur after administration of albuterol sulfate and budesonide, components of AIRSUPRA, as demonstrated by cases of anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, rash, and urticaria. Discontinue AIRSUPRA if such reactions occur
• Risk of Sympathomimetic Amines with Certain Coexisting Conditions: AIRSUPRA, like all therapies containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines
• Hypokalemia: Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients. The decrease in serum potassium is usually transient, not requiring supplementation
• Immunosuppression and Risk of Infections: Due to possible immunosuppression from the use of inhaled corticosteroids (ICS), potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients
• Oropharyngeal Candidiasis: Has occurred in patients treated with ICS agents. Monitor patients periodically. Advise patients to rinse his/her mouth with water, if available, without swallowing after inhalation
• Hypercorticism and Adrenal Suppression: May occur with very high doses in susceptible individuals. If such changes occur, consider appropriate therapy
• Reduction in Bone Mineral Density: Decreases in bone mineral density have been observed with long-term administration of ICS. For patients at high risk for decreased bone mineral density, assess initially and periodically thereafter
• Glaucoma and Cataracts: Have been reported following the long-term administration of ICS, including budesonide, a component of AIRSUPRA
• Effects on Growth: Orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of AIRSUPRA have not been established in pediatric patients, and AIRSUPRA is not indicated for use in this population
• Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, and dysphonia
• Drug Interactions: AIRSUPRA should be administered with caution to patients being treated with:
  • Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects)
  • Short-acting bronchodilators (concomitant use of additional beta-agonists with AIRSUPRA should be used judiciously to prevent beta-agonist overdose)
  • Beta-blockers (may block pulmonary effects of beta-agonists and produce severe bronchospasm)
  • Diuretics or non-potassium-sparing diuretics (may potentiate hypokalemia or ECG changes). Consider monitoring potassium levels
  • Digoxin (may decrease serum digoxin levels). Consider monitoring digoxin levels
  • Monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants (Use AIRSUPRA with extreme caution; may potentiate effect of albuterol on the cardiovascular system)

• Use AIRSUPRA with caution in patients with hepatic impairment, as budesonide systemic exposure may increase. Monitor patients with hepatic disease

INDICATION

AIRSUPRA is a combination of albuterol, a beta₂-adrenergic agonist and budesonide, a corticosteroid, indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

BREZTRI AEROSPHERE^® (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol

• BREZTRI is contraindicated in patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or product excipients
• BREZTRI is not indicated for treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of asthma-related death. These findings are considered a class effect of LABA monotherapy. When a LABA is used in 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 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, 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 beta2-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
• 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 in a 52-week trial (incidence ≥ 2%) were upper respiratory tract infection (5.7%), pneumonia (4.6%), back pain (3.1%), oral candidiasis (3.0%), influenza (2.9%), muscle spasms (2.8%), urinary tract infection (2.7%), cough (2.7%), sinusitis (2.6%), and diarrhea (2.1%). In a 24-week trial, adverse reactions (incidence ≥ 2%) were dysphonia (3.3%) and muscle spasms (3.3%)
• 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

INDICATION

BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

LIMITATIONS OF USE

Not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Please see full BREZTRI Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

FASENRA ^® (benralizumab)

CONTRAINDICATIONS

Known hypersensitivity to benralizumab or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.

Acute Asthma Symptoms or Deteriorating Disease

FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis.

Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo in asthma exacerbation studies.

USE IN SPECIFIC POPULATIONS

The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

INDICATIONS

FASENRA is indicated for:

• the add-on maintenance treatment of patients with severe asthma aged 6 years and older and with an eosinophilic phenotype. FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus
• the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)

Please read accompanying Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

TEZSPIRE^® (tezepelumab-ekko)

INDICATION

TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

CONTRAINDICATIONS

Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.

Acute Asthma Symptoms or Deteriorating Disease

TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.

Live Attenuated Vaccines

The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.

USE IN SPECIFIC POPULATIONS

There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

Notes

Data presented does not reflect any head-to-head comparisons.

Asthma

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,²⁵ including over 25 million in the US.²⁶

Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.²⁷ These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.^28,29 There are an estimated 136 million asthma exacerbations globally per year,³⁰ including more than 10 million in the US²⁶; these are physically threatening and emotionally significant for many patients³¹ and can be fatal.^25,32

Severe asthma is an often-debilitating, potentially fatal condition affecting up to 26 million people worldwide.^25,32-34 Patients may be uncontrolled despite high dosages of standard of care asthma controller medicines, experiencing frequent exacerbations and significant limitations on lung function and health-related quality of life as a result.^32-35

Inflammation is central to both asthma symptoms²⁸ and exacerbations.³⁶ Many patients experiencing asthma symptoms use a short-acting beta agonists (SABA) (e.g. albuterol) as a rescue medicine;^37-39 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,⁴⁰ which can result in impaired quality of life,⁴¹ hospitalization and frequent oral corticosteroid (OCS) use.⁴¹ Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.⁴² International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.²⁷

Chronic Obstructive Pulmonary Disease (COPD)

COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems.⁴³ It affects an estimated 391 million people around the world and is the third leading cause of death globally.^44,45

The lungs and heart are fundamentally linked and work together.⁴⁶ COPD mechanisms elevate the risk of both lung and heart events, including severe or even fatal COPD exacerbations and cardiac events, known as cardiopulmonary risk.^47-51 Approximately 1 in 5 patients with COPD will die within a year of their first hospitalization for an exacerbation, and pulmonary and cardiac events are a key driver of mortality and the most common reasons for death in patients with COPD.^47,52-54

Eosinophilic granulomatosis with polyangiitis (EGPA)

EGPA, formerly known as Churg-Strauss Syndrome, is a rare, immune-mediated inflammatory disease that is caused by inflammation of small to medium-sized blood vessels.^55,56 It is estimated that 118,000 people throughout the world live with EGPA.⁵⁷

EGPA can result in damage to multiple organs, including lungs, upper airway, skin, heart, gastrointestinal tract and nerves.⁵⁵ The most common symptoms and signs include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath. Without treatment, the disease may be fatal.^55,58 Almost half (47%) of patients do not achieve remission with current treatments.⁵⁹

AIRSUPRA

AIRSUPRA (albuterol/budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pressurised metered-dose inhaler (pMDI) using AstraZeneca’s AEROSPHERE delivery technology.⁶⁰

Outside of the US, AIRSUPRA is also approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman.

BREZTRI AEROSPHERE

BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate), approved under the brand name TRIXEO in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting beta-agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonists (LAMA, with budesonide, an inhaled corticosteriod (ICS), and delivered via the AEROSPHERE pressurized metered-dose inhaler. BREZTRI AEROSPHERE is approved to treat COPD in more than 50 countries worldwide including the US, EU, China and Japan, and is currently being studied in Phase III trials for asthma.

FASENRA

FASENRA (benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).⁶¹ FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan, China and other countries, and is approved for self-administration in the US, EU and other countries.

FASENRA was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

TEZSPIRE

TEZSPIRE (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.^62,63 TEZSPIRE is approved in the US, EU, Japan and other countries for the treatment of severe asthma.^65-67

Amgen collaboration

In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue.

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 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 operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca.

References

1. Panettieri R, et al. Efficacy Of As-needed Albuterol‒budesonide Versus Albuterol On Systemic Corticosteroid Exposure In Participants With Mild Asthma: BATURA Prespecified Analysis. [Poster Discussion Session]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

2. Chipps B, et al. As-needed Albuterol-budesonide Decreases Risk of Severe Asthma Exacerbation in the First Three Months Post-randomization Compared to As-needed Albuterol in Patients Treated for Moderate-to-Severe Asthma: MANDALA Post-Hoc Analysis. [Thematic Poster Session]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

3. N. Chase, D. Beuther, H. Naddaf, et al. Baseline Characteristics Of Patients With Asthma Initiating Albuterol-budesonide Rescue: A Real-world US Claims-based Study. [Thematic Poster Session]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

4. Singh D, Marshall J, Martinez FJ, et al. Cardiopulmonary risk benefits of budesonide/glycopyrrolate/formoterol fumarate triple therapy: a number needed to treat post hoc analysis of the ETHOS trial. [Mini Symposium]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

5. Pollack M, Tkacz J, Schinkel J, et al. Reduced COPD exacerbation risk with prompt initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) after a COPD exacerbation among patients with COPD and concurrent asthma: The MITOS EROS+CP (US) Study. [Poster Discussion]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

6. Pollack M, Tkacz J, Schinkel J, et al. Prompt initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) after an exacerbation is associated with reduced exacerbation and cardiopulmonary risk in patients with COPD: The MITOS EROS+CP (US) Study. [Mini Symposium]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

7. Marshall J, Munehiro S, Sadafi H, et al. In silico lung deposition of budesonide/glycopyrrolate/formoterol fumarate in patients with COPD and concomitant asthma [Thematic Poster]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

8. Wechsler M.E, Nair P, Khalidi N, et al. Two-Year Efficacy and Safety of Benralizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis. [Poster Discussion]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

9. Lukka PB, Penland RC, Brekkan A, et al. Model-based Comparison Of The Pharmacokinetic/Pharmacodynamic And Eosinophilic Response Of Benralizumab Versus Depemokimab At 12 Weeks. [Thematic Poster]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

10. Carstens DD, Harrison A, Meyers DA, et al. Lung Function Improvement in Patients With Uncontrolled, Moderate-to-Severe Asthma Treated With Benralizumab: A New, Retrospective Analysis of the Pooled Sirocco and Calima Studies. [Mini Symposium]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

11. Jackson DJ, Lugogo NL, Gurnell M, et al. Tezepelumab Reduces and Eliminates OCS Use in OCS-Dependent Patients with Severe Asthma: Primary Results From the Phase 3b WAYFINDER Study. [Mini Symposium]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

12. Laidlaw T, Peters A, Han JK, et al. Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps in patients with and without co-morbid asthma: results from the WAYPOINT study. [Late-Breaking Poster]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

13. Han MK, Drummond BM, Criner GJ, et al. Effect of Tezepelumab on Exacerbations in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease Based on Inclusion or Exclusion of Antibiotic Use in the Definition of Moderate Exacerbations: Data from the Phase 2a COURSE Study. [Thematic Poster]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

14. Saraiva G, Li J, Brooks D, et al. Safety Profile of Tozorakimab (an Anti-IL-33 Monoclonal Antibody): Data from the FRONTIER Phase 2 Program of 1076 Patients. [Thematic Poster]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

15. McCormack M, Nordon C, Carstens D, et al. Clinical Characteristics and Burden of Illness in People With COPD Experiencing Exacerbations While on Inhaled Triple Therapy, Stratified by Smoking Status. [Thematic Poster]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

16. Yehya N, Maslova E, Fagerås M, et al. Treatments patterns in US patients hospitalized for viral lower respiratory tract disease: an analysis of linked electronic health records and claims data (2015-2023). [Poster Discussion]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

17. Long MB, Hull RC, Gilmour A, et al. A bispecific monoclonal antibody targeting Psl and PcrV for chronic Pseudomonas aeruginosa infection in patients with bronchiectasis: results from a randomized, double-blind placebo-controlled trial (GREAT-2). [Late-Breaking Poster]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

18. Odqvist L, Douglasson H, Leffler A, et al. AZD6793, A Novel IRAK4 Inhibitor, Targets Multiple Disease-relevant Pathways in Pre-clinical Models of Chronic Obstructive Pulmonary Disease. [Poster Discussion]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

19. Quint JK, et al. Rational use of inhaled corticosteroids for the treatment of COPD. NPJ Prim Care Respir Med. 2023;33:27.

20. Chen S, et al. Symptomatic burden of COPD for patients receiving dual or triple therapy. Int J Chron Obstruct Pulmon Dis. 2018;13:1365-1376.

21. Craster A, et al. Deep learning-based quantitative CT and proteomics for predicting outcomes in idiopathic pulmonary fibrosis. [Mini Symposium]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

22. Walsh SLF, Sherlock SP, Ostridge K et al. Deep learning-based short-term disease progression evaluation supersedes automated baseline CT phenotype in predicting outcomes in idiopathic pulmonary fibrosis. [Mini Symposium]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

23. Walsh S, Kanavati F, Montiero M et al. Deep learning-based Quantitative CT and CT phenotype classification independently predict mortality in idiopathic pulmonary fibrosis, a prospective observational cohort study. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

24. Azim A, Angermann B, Platt A. Identifying clinically relevant biomarkers of mild-stage emphysema in COPD patients via interpretable machine learning. [Mini Symposium]. Presented at the American Thoracic Society International Conference 2025 (16-21 May).

25. Global Asthma Network. The Global Asthma Report 2022. Available at: http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf. [Last accessed: May 2025].

26. CDC. Most Recent National Asthma Data. Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. [Last accessed: May 2025].

27. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2022. Available at: https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf. [Last accessed: May 2025].

28. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009.

29. Papi A, et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract. 2018; 6 (6): 1989-98.e3.

30. AstraZeneca Data on File. Budesonide/formoterol Data on File: Annual Rate of Asthma Exacerbations Globally. REF-173201.

31. Sastre J, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016; 9: 13.

32. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372.

33. Chung KF, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73.

34. Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005;172:149-60.

35. Peters SP, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006;100(7):1139-51.

36. Wark PA, et al. Asthma exacerbations 3: pathogenesis. Thorax. 2006; 61 (10): 909-15.

37. Johnson DB, et al. Albuterol. 2022 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. PMID: 29489143.

38. Montemayor T, et al. Albuterol: Often Used and Heavily Abused. Respiratory Care November 2021, 66 (Suppl 10) 3603775.

39. ClinCalc.com. Albuterol: Drug Usage Statistics, US 2013 – 2020. Available at: https://clincalc.com/DrugStats/Drugs/Albuterol. [Last accessed: May 2025].

40. Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020; 55 (4): 1901872.

41. Lloyd A, et al. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007; 16 (1): 22-7.

42. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204.

43. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2023. Available at: http://goldcopd.org. [Last accessed: May 2025].

44. Adeloye D, et al. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. (2022) Vol 10(5); 447-458.

45. World Health Organization. The Top 10 Causes of Death. Accessible at: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death. [Last accessed: May 2025].

46. American Lung Association. Your Heart and Lungs: The Ultimate Relationship (2023) Available at: https://www.lung.org/blog/heart-lung-relationship. [Last accessed: May 2025].

47. Ho TW, Tsai YJ, Ruan SY, et al. In-Hospital and One-Year Mortality and Their Predictors in Patients Hospitalized for First-Ever Chronic Obstructive Pulmonary Disease Exacerbations: A Nationwide Population-Based Study. PLOS ONE. 2014; 9 (12): e114866.

48. Donaldson GC, et al. Increased risk of myocardial infarction and stroke following exacerbation of COPD. Chest. 2010;137:1091-1097;9-2029.

49. Watz H, et al. Spirometric changes during exacerbations of COPD: A post hoc analysis of the WISDOM trial. Respir Res. 2018;19(1):251.

50. Suissa S, et al. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax. 2012;67(11):957-963.

51. Swart K, Baak B, Lemmens L, et al. Risk of cardiovascular events after an exacerbation of chronic obstructive pulmonary disease: results from the EXACOS-CV cohort study using the PHARMO Data Network in the Netherlands. Respiratory Research. (2023) Vol 24: 293.

52. Lindenauer PK, Dharmarajan K, Qin L, et al. Risk Trajectories of Readmission and Death in the First Year After Hospitalization for Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1009-1017.

53. García-Sanz MT, Cánive-Gómez JC, Senín-Rial L, et al. One-year and long-term mortality in patients hospitalized for chronic obstructive pulmonary disease. J Thorac Dis. 2017; 9 (3): 636‐645.

54. Mannino DM, et al. Global Initiative on Obstructive Lung Disease (GOLD) classification of lung disease and mortality: findings from the Atherosclerosis Risk in Communities (ARIC) study. Respir Med. 2006;100: 115-122.

55. American Partnership for Eosinophilic Disorders. Eosinophilic Granulomatosis with Polyangiitis (EGPA). Available at: https://apfed.org/about-ead/eosinophilic-granulomatosis-with-polyangiitis/. [Last accessed: May 2025].

56. Furuta S, Iwamoto T, Nakajima H. Update on eosinophilic granulomatosis with polyangiitis. Allergol Int. 2019;68:430-436.

57. AstraZeneca Data on file. 2022. REF-167820.

58. Baldini C, et al. Clinical Manifestations and Treatment of Churg-Strauss Syndrome. Rheum Dis Clin N Am. 2010;36:527-543.

59. Wechsler ME, et al. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017:376;1921-1932.

60. AstraZeneca news release. Airsupra (PT027) approved in the US for asthma. Available at https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html. [Last accessed: May 2025].

61. AstraZeneca. Fasenra Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf. [Last accessed: May 2025].

62. Corren J, et al. Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated April 18, 2019]. N Engl J Med. 2017;377:936-946.

63. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.

64. AstraZeneca news release. Tezspire (tezepelumab) approved in the US for severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html. [Last accessed: May 2025].

65. AstraZeneca news release. Tezspire (tezepelumab) approved in the US for severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html. [Last accessed: May 2025].

66. AstraZeneca news release. Tezspire approved in the EU for the treatment of severe asthma. 2022. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html. [Last accessed: May 2025].

67. AstraZeneca news release. Tezspire approved in Japan for the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html. [Last accessed: May 2025].

Last Updated 5/2025

View source version on businesswire.com: https://www.businesswire.com/news/home/20250513177057/en/