First and only biologic approved in the EU in patients with severe asthma 

AstraZeneca’s Tezspire (tezepelumab) has been approved in the European Union as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product. 

The approval by the European Commission was based on results from the Pathfinder clinical trial programme, which included the pivotal Navigator Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.¹ The approval follows the recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July 2022. 

Tezspire is the first and only biologic approved in Europe for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine.^1-4 Tezspire consistently and significantly reduced asthma exacerbations across the Pathway Phase II and the Navigator Phase 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).^1,2

In clinical trials, the most common adverse events in patients who received Tezspire were pharyngitis, rash, arthralgia and injection site reactions.⁵

Results from the Navigator Phase III trial were published in The New England Journal of Medicine in May 2021. Tezspire has been approved in the US and other countries for the treatment of severe asthma, and regulatory reviews are ongoing in additional countries around the world.⁶

Official comments 

Professor Guy Brusselle, Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium, said: “Severe asthma is a complex disease given approximately 60% of patients have multiple drivers of inflammation. With the European approval of Tezspire, a first-in-class biologic acting at the top of the inflammation cascade, we have an opportunity to treat a broader population of patients with severe asthma, fulfilling a high unmet need in this disease.” 

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Severe asthma continues to have a debilitating impact for people living with the disease, with many patients experiencing frequent exacerbations, an increased risk of hospitalisation and a significantly reduced quality of life. Tezspire is now the first and only biologic approved in Europe for patients with severe asthma with no phenotype or biomarker limitation and we look forward to bringing this important medicine to patients as quickly as possible.” 

References 

1. 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.
2. Corren J, et al. Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated April 18, 2019]. N Engl J Med. 2017;377: 936-946.
3. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595
4. 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
5. European Medicines Agency. Tezspire Summary of Committee for Medicinal Products for Human Use Opinion Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tezspire [Last accessed: July 2022].
6. Tezspire (tezepelumab) US prescribing information; 2021