Latest news with #SharonBarr
Yahoo
20-05-2025
- Business
- Yahoo
AstraZeneca PLC (AZN) Trial: Airsupra Cuts Severe Asthma Risk by 47%
AstraZeneca PLC (NASDAQ:AZN), a pharmaceutical and biotech firm based in Cambridge, UK, reported positive results from its Phase 3b Batura trial. The study found that Airsupra, its dual-action asthma rescue inhaler, led to meaningful improvements in patients with mild asthma compared to albuterol alone. AIRSUPRA is the only FDA-approved rescue inhaler designed to both relieve asthma symptoms and help prevent asthma attacks. It is a pressurized metered-dose inhaler that combines albuterol and budesonide. The FDA approved the inhaler in January 2023 for use as needed to manage or prevent asthma symptoms and reduce the risk of sudden, severe breathing issues in adults aged 18 and older. In a recent trial, the results showed that Airsupra reduced the risk of severe asthma flare-ups by 47% versus placebo. In addition, patients using the inhaler had 63% less exposure to systemic corticosteroids during treatment, lowering the risk of long-term side effects such as type 2 diabetes, mental health issues, kidney problems, cataracts, heart disease, pneumonia, and bone fractures. Sharon Barr, Executive Vice-President and Head of BioPharmaceuticals R&D, AstraZeneca PLC (NASDAQ:AZN), made the following statement: 'The exciting results from the BATURA trial, coupled with the findings from MANDALA and DENALI, clearly demonstrate the superiority of Airsupra over albuterol alone across all asthma severities. We hope these comprehensive results accelerate the use of anti-inflammatory rescue therapy as the preferred standard of care, in line with recommendations from the Global Initiative for Asthma.' Airsupra made a favorable contribution to AstraZeneca PLC (NASDAQ:AZN)'s earnings and has the potential to play a more significant role in future profits, particularly in light of the recent trial results. In fiscal year 2024, Airsupra brought in $66 million in revenue. While we acknowledge the potential of AZN to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AZN and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: and Disclosure. None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-05-2025
- Business
- Yahoo
AstraZeneca PLC (AZN) Trial: Airsupra Cuts Severe Asthma Risk by 47%
AstraZeneca PLC (NASDAQ:AZN), a pharmaceutical and biotech firm based in Cambridge, UK, reported positive results from its Phase 3b Batura trial. The study found that Airsupra, its dual-action asthma rescue inhaler, led to meaningful improvements in patients with mild asthma compared to albuterol alone. AIRSUPRA is the only FDA-approved rescue inhaler designed to both relieve asthma symptoms and help prevent asthma attacks. It is a pressurized metered-dose inhaler that combines albuterol and budesonide. The FDA approved the inhaler in January 2023 for use as needed to manage or prevent asthma symptoms and reduce the risk of sudden, severe breathing issues in adults aged 18 and older. In a recent trial, the results showed that Airsupra reduced the risk of severe asthma flare-ups by 47% versus placebo. In addition, patients using the inhaler had 63% less exposure to systemic corticosteroids during treatment, lowering the risk of long-term side effects such as type 2 diabetes, mental health issues, kidney problems, cataracts, heart disease, pneumonia, and bone fractures. Sharon Barr, Executive Vice-President and Head of BioPharmaceuticals R&D, AstraZeneca PLC (NASDAQ:AZN), made the following statement: 'The exciting results from the BATURA trial, coupled with the findings from MANDALA and DENALI, clearly demonstrate the superiority of Airsupra over albuterol alone across all asthma severities. We hope these comprehensive results accelerate the use of anti-inflammatory rescue therapy as the preferred standard of care, in line with recommendations from the Global Initiative for Asthma.' Airsupra made a favorable contribution to AstraZeneca PLC (NASDAQ:AZN)'s earnings and has the potential to play a more significant role in future profits, particularly in light of the recent trial results. In fiscal year 2024, Airsupra brought in $66 million in revenue. While we acknowledge the potential of AZN to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AZN and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: and Disclosure. None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
02-05-2025
- Health
- Business Wire
BREZTRI met primary endpoints in KALOS and LOGOS Phase III trials in asthma
WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca's fixed-dose triple-combination therapy BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines. KALOS and LOGOS were replicate, randomized, double-blind trials designed to investigate BREZTRI as a potential treatment for asthma. 1,2 The trials evaluated the efficacy and safety of BREZTRI versus maintenance treatment with ICS/LABA in adults and adolescents with uncontrolled asthma. 1,2 Asthma is a common, chronic respiratory disease characterized by inflammation and muscle tightening in the airway (bronchoconstriction), which can make it difficult to breathe. 3 As many as 262 million people worldwide are affected by asthma, 3 and it is estimated that nearly half of those treated with dual therapy remain uncontrolled, which can significantly limit lung function and decrease quality of life. 4,5 Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: 'Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing, significantly impacting their ability to perform daily activities. The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of budesonide/glycopyrronium/formoterol to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy.' Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: 'We are excited by the positive results from the KALOS and LOGOS trials, which demonstrate that BREZTRI could help improve the lives of the millions of patients living with asthma. These asthma data build on the well-established profile of BREZTRI in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients.' There were no new safety or tolerability signals identified for BREZTRI in KALOS or LOGOS. Full results from the two Phase III trials will be shared with regulatory authorities and presented at an upcoming medical meeting. BREZTRI is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide including the US, EU, China and Japan. IMPORTANT SAFETY INFORMATION 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. Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide, 3 including over 25 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. 3,7 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. 4,5 KALOS and LOGOS Phase III trials KALOS and LOGOS are replicate confirmatory, randomized, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of BGF (320/28.8/9.6μg and 320/14.4/9.6μg) compared with two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: PT009 (in anAEROSPHERE inhaler) and SYMBICORT pressurized metered-dose inhaler (pMDI). 1,2 KALOS and LOGOS included approximately 4,400 randomized patients. The trial design was optimized to evaluate the 320/28.8/9.6μg dose of BGF. The primary efficacy 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. 1,2 In addition to the two registrational trials, KALOS and LOGOS, two qualifying trials, LITHOS and VATHOS, 8,9 also met their primary endpoints. LITHOS and VATHOS included approximately 1,000 randomized patients. 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 and follow us on social media @AstraZeneca. References Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) [Online]. Available at: [Last accessed: May 2025]. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS) [Online]. Available at: [Last accessed: May 2025]. Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: [Last accessed: May 2025]. 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. U.S. Centers for Disease Control and Prevention (CDC). Most Recent National Asthma Data. [Online]. Available at: [Last accessed: May 2025]. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372. A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS) [Online]. Available at: [Last Accessed: May 2025]. A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants with Inadequately Controlled Asthma (VATHOS) [Online]. Available at: [Last Accessed: May 2025]. AstraZeneca Data on File. 2025. REF-270910.
Yahoo
01-04-2025
- Health
- Yahoo
AstraZeneca's AZD0780 cuts LDL-C by 50% in Phase IIb trial
AstraZeneca's AZD0780 has demonstrated significant efficacy in a Phase IIb trial, showing a 50.7% reduction in LDL-C after 12 weeks when added to standard statin therapy. The treatment helped 84% of participants reach the recommended LDL-C target, compared to just 13% with statins alone. The PURSUIT trial sought to compare the placebo to the company's first oral small molecule modulator, designed for the treatment of dyslipidemia, when used alongside lipid-lowering statin therapy, the current standard of care in many cholesterol-related conditions. The primary endpoint of the dose-finding trial sought to measure the effect of different doses of AZD0780 given once daily across differing levels of LDL-C in patients, with similar levels of efficacy observed regardless of whether patients had received moderate or high-intensity statin doses at the time of baseline measurement. The therapy comes in response to research published in the journal Postgraduate Medicine that estimates as much as 70% of patients globally are currently not reaching guideline-recommended LDL-C targets. The results were announced as part of the American College of Cardiology's (ACC) Annual Scientific Expo in Chicago and suggest AZD0780 could provide a new, convenient option for patients struggling to meet cholesterol goals despite existing therapies. The trial's principal investigator Michael J Koren said: 'The PURSUIT Phase IIb trial demonstrates the potential of AZD0780 to provide a much-needed once-daily oral treatment option to deliver greater LDL cholesterol lowering on top of standard of care for millions of patients who remain at risk for serious cardiovascular events, including premature death. 'These results are particularly important because the majority of patients with atherosclerotic disease today do not reach their LDL-C goals, despite the availability of lipid-lowering therapies such as statins and injectable PCSK9 inhibitors.' Research by GlobalData estimates that should AZD0780 make it to market it is predicted to bring in $46m for AstraZeneca, with that figure forecasted to grow to $462m by the end of 2031. GlobalData is the parent company of Clinical Trials Arena. AstraZeneca's executive vice president Sharon Barr said: 'These new data reflect AZD0780's ability to reduce LDL cholesterol in patients who need more options to manage their cholesterol and related risks when standard-of-care therapy is not enough.' Elsewhere at the ACC Annual Expo, Cleerly has announced interim results from a trial, described as the largest-ever cardiovascular phenotype outcomes study, finding that women living with chronic coronary artery disease (CAD) are at higher risk of major adverse coronary events. Meanwhile, Eli Lilly has reported promising Phase II results for lepodisiran, its experimental therapy aimed at reducing lipoprotein(a). "AstraZeneca's AZD0780 cuts LDL-C by 50% in Phase IIb trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
01-03-2025
- Health
- Yahoo
Positive results from the TEZSPIRE Phase III WAYPOINT trial highlight rapid and sustained effect in chronic rhinosinusitis with nasal polyps
TEZSPIRE significantly reduced nasal congestion, polyp size and nearly eliminated the need for surgery in patients with chronic rhinosinusitis with nasal polyps WAYPOINT data published in New England Journal of Medicine and highlighted as late-breaking oral presentation at AAAAI/WAO 2025 WILMINGTON, Del., March 01, 2025--(BUSINESS WIRE)--Full results from the positive Phase III WAYPOINT trial showed AstraZeneca and Amgen's TEZSPIRE® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for subsequent surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.1,2 These data were published in the New England Journal of Medicine and presented today as a late-breaking oral presentation at the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, CA.1,2 Treatment with TEZSPIRE significantly reduced nasal polyp severity measured by the co-primary endpoints; Nasal Polyp Score (NPS) by -2.065 (95% CI: -2.389, -1.742; p<0.0001) and nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 (95% CI: -1.201, -0.855; p<0.0001) at week 52 compared to placebo.1,2 Improvements in NPS were observed as early as week four and NCS as early as week two (the first post-treatment assessment respectively) and were sustained through week 52.1 Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population.1 Importantly, TEZSPIRE significantly reduced the need for subsequent nasal polyp surgery by 98% (p<0.0001) and the need for systemic corticosteroid treatment by 88% ( p<0.0001) compared to placebo.1 Dr Joseph Han, Vice Chair of Department of Otolaryngology - Head and Neck Surgery, Old Dominion University, US, and co-primary investigator in the trial, said: "Many patients living with nasal polyps are at risk of repeat surgeries and serious systemic side effects from long-term oral corticosteroids. The WAYPOINT results are clinically meaningful and suggest that tezepelumab could greatly reduce the burden of nasal polyps for patients by nearly eliminating the need for future surgery and corticosteroid use and by significantly reducing nasal polyp size and congestion." Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said, "The WAYPOINT results demonstrate the potential for TEZSPIRE to provide a much-needed option for patients with chronic rhinosinusitis with nasal polyps. With its first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, the data add to the body of evidence that tezepelumab can transform care for patients with epithelial-driven inflammatory diseases." Table M1: Summary of co-primary and key secondary efficacy endpoints1,2 Endpoint Tezepelumab (n=203) Placebo (n=205) Difference vs. Placebo (95% CI) Co-primary endpoints Total nasal polyp score (range 0-8)* -2.458 (0.114) -0.392 (0.118) -2.065 (-2.389, -1.742) p<0.0001** Nasal congestion score (range 0-3)* -1.743 (0.062) -0.715 (0.064) -1.028 (-1.201, -0.855) p<0.0001** Key secondary endpoints Assessed in the overall trial population Time to first nasal polyp surgery decision (% patients)*** 0.5 (0.0, 2.5) 22.1 (16.4, 28.2) 0.02 (0.00, 0.09) p<0.0001** Time to first systemic glucocorticoid use (% patients)*** 5.2 (1.1, 14.7) 18.3 (13.3, 24.1) 0.12 (0.04, 0.27) p<0.0001** Time to nasal polyp surgery decision and/or systemic glucocorticoid use (% patients)*** 5.7 (1.3, 15.0) 30.6 (24.2, 37.1) 0.08 (0.03, 0.17) p<0.0001** Loss of smell score (range 0-3)* -1.26 (0.06) -0.26 (0.06) -1.00 (-1.18, -0.83) p<0.0001** Sino-Nasal Outcome Test-22 (SNOT-22) total score (range 0-110)* -45.02 (1.81) -17.76 (1.84) -27.26 (-32.32, -22.21) p<0.0001** Sinus Computed Tomography Lund–Mackay (CT-LMK) score (range 0-24)* -6.27 (0.24) -0.55 (0.24) -5.72 (-6.39, -5.06) p<0.0001** Total Symptom Score (TSS) (range 0-24)* -10.39 (0.40) -3.50 (0.41) -6.89 (-8.02, -5.76) p<0.0001** Key secondary endpoint Assessed in a subset of patients with co-morbid asthma or nonsteroidal anti-inflammatory drug exacerbated respiratory disease Pre-bronchodilator forced expiratory volume in 1 second (FEV1 in liters)* 0.02 (0.04) 0.03 (0.04) -0.01 (-0.12, 0.11) p=0.9362 *LS mean change (SE) from baseline at Week 52 **Denotes statistically significant at 0.01 level after adjustment for multiplicity. Unadjusted P-values are presented *** % patients from Kaplan Meier estimate (95% confidence interval) is provided for each treatment group, hazard ratio (95% confidence interval) is presented for the difference vs placebo. TEZSPIRE was generally well tolerated in patients with CRSwNP and had a safety profile consistent with its approved severe asthma indication.1,2 The most frequently reported adverse events for TEZSPIRE in the WAYPOINT trial were COVID-19, nasopharyngitis and upper respiratory tract infection.1 There were no clinically meaningful differences in safety results between the TEZSPIRE and placebo group.1 TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, Japan, and over 60 countries across the globe.3-5 It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.3,4 Regulatory filings for tezepelumab in CRSwNP are currently under review by regulatory authorities in multiple regions. INDICATION AND LIMITATION OF USE / ISI 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 and Instructions for Use. You may report side effects related to AstraZeneca products. Notes Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) CRSwNP is a complex inflammatory disorder, characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps.6,7 Nasal polyps and the accompanying inflammation can block nasal passages and lead to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life.8-10 Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologics.7,10-16 Phase III WAYPOINT trial WAYPOINT was a double-blind, multi-centre, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP.1,2,17 Participants received tezepelumab or placebo, administered via subcutaneous injection.1,2,17 The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period.1,17 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 thymic stromal lymphopoietin (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 epithelial-driven inflammation associated with severe asthma and other inflammatory diseases.18,19 TSLP is released in response to multiple epithelial triggers and insults (including allergens, viruses, bacteria, smoke, air pollution and other airborne particles) associated with asthma, CRSwNP, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other diseases.19,20 Expression of TSLP is increased in these patients and has been correlated with disease severity.10,18 Blocking TSLP can prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of exacerbations and improved disease control.18,19,21 Tezepelumab acts at the top of the inflammatory cascade and research indicates that targeting TSLP released by the airway and gastrointestinal epithelium may be a potential approach to treating other diseases in the future.18,22,23 TEZSPIRE is approved in the US, the EU and over 60 countries for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.3-5 Beyond CRSwNP, tezepelumab is also in development for other potential indications including COPD and EoE.24,25 In October 2021, tezepelumab was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of EoE. In July 2024, the US FDA granted a Breakthrough Therapy Designation for tezepelumab for the add-on maintenance treatment of patients with moderate to very severe COPD characterized by an eosinophilic phenotype. 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. Please visit and follow the Company on social media @AstraZeneca References Lipworth, BJ, Han JK, et al. Tezepelumab in adults with severe, uncontrolled CRSwNP. N Engl J Med. 2025. Lipworth, BJ, Han JK, et al. Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps: results from the Phase 3 WAYPOINT Study. [Late breaking oral presentation]. Presented at the American Academy of Allergy, Asthma & Immunology /World Allergy Organization Joint Congress 2025 (28 February – 03 March). 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Available at: [Last accessed: February 2025]. View source version on Contacts Media Inquiries Fiona Cookson +1 212 814 3923Jillian Gonzales +1 302 885 2677US Media Mailbox: usmediateam@ Sign in to access your portfolio
