First and only biologic to consistently and significantly reduce exacerbations in a broad population of severe asthma patients
MISSISSAUGA, ON, October 26, 2022 – Today, AstraZeneca and Amgen announced the Canadian availability of Tezspire™ (tezepelumab injection), indicated for the add-on maintenance treatment of adults and adolescents 12 years and older with severe asthma.1
Tezspire was approved based on results from the PATHWAY Phase llb trial and NAVIGATOR Phase III trial in which Tezspire demonstrated significant improvements across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.2
Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.2-5 It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase II and III clinical trials which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3,6-13 Tezspire is the only biologic approved for severe asthma with no phenotype (e.g., eosinophilic or allergic) or biomarker limitation within its approved label.1
“Patients with severe asthma often have difficulty achieving control of their disease because of its complex and heterogeneous nature. They face a significantly reduced quality of life, frequent exacerbations, and an increased risk of hospitalization,” said Dr. Anne Ellis, Professor of Medicine at Queen’s University, Chair of the Allergy/Immunology Department, and President of the Canadian Society of Allergy and Clinical Immunology. “Tezspire represents an important new treatment for many Canadian patients who remain underserved and continue to struggle with severe asthma.”
“With the approval of Tezspire, physicians are able to offer a new treatment that has the potential to transform care for a broad population of severe asthma patients in Canada,” said Kiersten Combs, President of AstraZeneca Canada. “Tezspire marks the first biologic treatment for severe asthma without phenotypic limitations and irrespective of biomarker levels."
"Tezspire introduces a new era in severe asthma management, in which a broad patient population will have a treatment option that controls inflammation at the source, regardless of the cause,” said Dr. Daniel Martinez, Executive Medical Director, Amgen Canada. “This is a true win for Canadian patients, providing a much-needed treatment option for a complex and debilitating disease."
In clinical studies, the most frequently reported adverse reactions in patients who received Tezspire were pharyngitis, arthralgia, and injection site reaction.1
Results from the NAVIGATOR Phase III trial were published in The New England Journal of Medicine in May 2021. There were no clinically meaningful differences in safety results between the Tezspire and placebo groups in the NAVIGATOR trial.2
Asthma is a heterogeneous disease affecting an estimated 339 million people worldwide, including an estimated 3.8 million Canadians.14-16 Asthma is the third most common chronic disease in Canada and 5%-10% of asthma patients have severe asthma.16,17 Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids (OCS), many severe asthma patients remain uncontrolled.15,18,19 Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.18-21
Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant impairment in lung function and a reduced quality of life.15,18, 22 Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma have twice the risk of asthma-related hospitalizations.23-25 There is also a significant socio-economic burden, with these patients accounting for approximately 50% of asthma-related costs.26
Tezspire (tezepelumab injection) is being developed by AstraZeneca in collaboration with Amgen and is a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of the inflammatory cascade and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.3,4 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.3,4 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.3,5 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.2,3,5 Tezspire acts at the top of the inflammation cascade and has the potential to help address a broad population of severe asthma patients irrespective of biomarker levels.2,3
Tezspire was approved by Health Canada in July 2022. Tezspire has also been approved in the US, EU, and Japan for the treatment of severe asthma, and regulatory reviews are ongoing in additional countries around the world.27
Tezspire is also in development for other potential indications including chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE).
AstraZeneca is a global, innovation-driven biopharmaceutical business with a focus on the discovery, development, and commercialization of medicines that transform lives. Our core scientific focus is in the areas of Cardiovascular, Renal and Metabolic (CVRM) disease; Oncology; Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, the company employs more than 1,200 people across Canada, including roughly 700 employees at our head office and clinical research hub in Mississauga, Ontario. For more information, please visit the company’s website at www.astrazeneca.ca.
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ontario's vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading healthcare, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca and follow us on www.twitter.com/amgencanadagm.
- Tezspire Canadian Product Monograph. Available at: https://www.astrazeneca.ca/en/our-medicines.html. [Last accessed: July 2022].
- Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384: 1800-1809. DOI: 10.1056/NEJMoa2034975.
- Corren J, et al. Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated April 18, 2019]. N Engl J Med. 2017;377: 936-946.
- Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595.
- Li Y, et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. J Immunol. 2018;200: 2253–2262.
- Hanania NA, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154 (9): 573-82.
- Yancey SW, et al. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150-300 cells/μL. Respir Med. 2019; 151: 139-141.
- FitzGerald JM, et al. Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. Lancet Respir Med. 2018; 6 (1): 51-64.
- Castro M, et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018; 378 (26): 2486-2496.
- Ortega HG, et al; on behalf of the MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207.
- Bleecker ER, et al, on behalf of the SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet 2016: 388 (10056): 2115-2127.
- FitzGerald JM, et al, on behalf of the CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016: 388(10056): 2128-2141.
- Wenzel S, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016 Jul 2;388(10039):31-44.
- The Global Asthma Network. The Global Asthma Report 2018. [Online]. Available at: http://globalasthmareport.org/resources/Global_Asthma_Report_2018.pdf. [Last accessed: December 2021].
- Chung KF, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43 (2): 343-373.
- Asthma Canada. Asthma Facts and Statistics. Available at: https://asthma.ca/wp-content/uploads/2020/07/Asthma-101.pdf. Last accessed July 2022
- FitzGerald JM, et al. Recognition and management of severe asthma: A Canadian Thoracic Society position statement. Canadian Journal of Respiratory, Critical Care, and Sleep Medicine. 2017; VOL. 1, NO. 4, 199–221.
- Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005; 172: 149-160.
- Peters SP, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006: 100 (7): 1139-51.
- Hyland ME, et al. A Possible Explanation for Non-responders, Responders and Super-responders to Biologics in Severe Asthma. Explor Res Hypothesis Med. 2019; 4: 35–38.
- Tran TN, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016; 116: 37–42.
- Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40: 364-372.
- Chastek B, et al. Economic Burden of Illness Among Patients with Severe Asthma in a Managed Care Setting. J Manag Care Spec Pharm. 2016;22: 848–861.
- Hartert TV, et al. Risk factors for recurrent asthma hospital visits and death among a population of indigent older adults with asthma. Ann Allergy Asthma Immunol. 2002;89: 467–73.
- 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.
- World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https://www.wordallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed: December 2021].
- Tezspire (tezepelumab) US prescribing information; 2021.