AstraZeneca Tezspire approved in the US for chronic rhinosinusitis with nasal polyps

AstraZeneca plc (LON:AZN) and Amgen’s Tezspire (tezepelumab) has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), a complex epithelial-driven inflammatory condition. Tezspire is the first and only biologic that targets thymic stromal lymphopoietin (TSLP) to be approved for CRSwNP.

The approval by the US Food and Drug Administration (FDA) was based on efficacy and safety data from the WAYPOINT Phase III trial, which were presented at the 2025 American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and simultaneously published in The New England Journal of Medicine.^1,2 In the trial, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity, and showed near-elimination of the need for surgery and significant reduction in systemic corticosteroid use vs. placebo.^1,2

Dr. Joseph Han, Vice Chair of Department of Otolaryngology – Head and Neck Surgery, Old Dominion University, US, and co-primary investigator in the WAYPOINT trial, said: “Over 320 million lives globally are disrupted by chronic rhinosinusitis with nasal polyps. The FDA approval of Tezspire brings forward a new treatment option that has demonstrated rapid and sustained symptom improvement, nearly eliminating the need for future surgeries and significantly reducing systemic steroid use. By targeting TSLP at the top of the inflammatory cascade, Tezspire offers a novel option for patients who continue to endure the disruption of this disease despite available treatments.”

Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA), said: “Chronic rhinosinusitis with nasal polyps is a persistent and often-overlooked disease that can significantly impact daily life, robbing patients of their ability to breathe without congestion and full sense of smell. This approval introduces an innovative treatment option for patients with the potential to help address the ongoing cycle of debilitating symptoms, surgeries and systemic steroid use.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said: “Today’s approval of Tezspire in chronic rhinosinusitis with nasal polyps expands the reach of this innovative treatment option to patients living with an epithelial-driven inflammatory disease beyond severe asthma. Building on the widespread, established use of Tezspire in severe asthma, this exciting milestone now reinforces its unique mechanism of action across both the upper and lower airways andreflects our commitment to transforming care for patients who face the daily burden of chronic respiratory and immune-mediated diseases.”

CRSwNP affects up to approximately 320 million people worldwide and is a complex epithelial-driven inflammatory condition characterised by persistent inflammation and benign polyp growths within the nasal cavity. People living with CRSwNP commonly experience airflow obstruction and symptoms including congestion and an impaired sense of smell.^3-7 For many patients, current therapies such as systemic and intranasal corticosteroids and repeated sinus surgeries do not offer lasting relief.⁴

The safety profile and tolerability of Tezspire in the WAYPOINT trial was generally consistent with the known profile of the medicine.¹ The most frequently reported adverse events in the trial were COVID-19, nasopharyngitis and upper respiratory tract infection.¹ 

The Committee for Medicinal Products for Human Use (CHMP) recently adopted a positive opinion for the approval of Tezspire in the EU for treatment of CRSwNP.⁸ Regulatory applications are currently under review in the EU, China, Japan and several other countries.

Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and more than 60 countries across the globe.^9-11

References

1. Lipworth BJ, Han JK, et al. Tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps. N Engl J Med. 2025;392(12):1178-1188. DOI: 10.1056/NEJMoa2414482.
2. 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).
3. Bachert C, et al. Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2016;4(4):621-628.
4. Del Toro E, Portela J. Nasal Polyps. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. Available at: https://www.ncbi.nlm.nih.gov/books/NBK560746/. Accessed October 2025.
5. Stevens WW, et al. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016; 4(4):565-572.
6. Abdalla S, et al. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales National prospective audit. Clin Otolaryngol. 2012;37(4):276-282.
7. Chen S, et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911.
8. AstraZeneca news release. Tezspire recommended for approval in the EU by CHMP for chronic rhinosinusitis with nasal polyps. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-recommended-for-approval-in-eu-for-crswnp.html. Accessed October 2025.
9. TEZSPIRE (tezepelumab) US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf. Accessed October 2025.
10. TEZSPIRE (tezepelumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tezspire-epar-product-information_en.pdf. Accessed October 2025.
11. 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. Accessed October 2025.