AstraZeneca Plc (LON:AZN) and Amgen’s Tezspire (tezepelumab) has been recommended for approval in the European Union (EU) for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results 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 WAYPOINT trial, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity, as measured by the co-primary endpoints; Nasal Polyp Score (NPS) by -2.08 (95% CI: -2.40, -1.76; p<0.001) and nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.04 (95% CI: -1.21, -0.87; p<0.001) at week 52 compared to placebo.1,2 Data also showed Tezspire enabled near-complete elimination of the need for surgery (98%) and significantly reduced the need for systemic corticosteroid treatment (89%) compared to placebo.2
Dr. Oliver Pfaar, Chair of the Section Rhinology and Allergy, ENT-Department, University Hospital Marburg, Philipps-Universität Marburg in Marburg, Germany and investigator in the WAYPOINT trial, said: “Chronic rhinosinusitis with nasal polyps is a challenging condition. For many patients, current therapies don’t offer lasting relief causing a cycle of repeat surgeries and ongoing treatment with oral corticosteroids, which can result in serious side effects. This positive CHMP recommendation is very encouraging and if approved, tezepelumab will provide patients and clinicians in Europe with an important new treatment option that has demonstrated rapid, sustained symptom relief.”
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The CHMP recommendation brings us closer to offering Tezspire to patients across the EU who face the daily challenges of this disruptive and difficult-to-treat disease. The unique way Tezspire works means it addresses the multiple drivers of epithelial-driven inflammation associated with chronic rhinosinusitis with nasal polyps. This pivotal milestone builds upon Tezspire’s foundational impact in severe asthma and reinforces our commitment to transforming respiratory care.”
CRSwNP is a chronic inflammatory condition characterised by persistent inflammation and benign polyp growths within the nasal cavity that can obstruct airflow and impair sense of smell, taste and sleep.3-7 This condition affects up to roughly 320 million people worldwide.7 Nearly half of the patients diagnosed with CRSwNP in Europe remain uncontrolled, and for many patients, current therapies such as systemic corticosteroids and repeated sinus surgeries do not offer lasting relief.4,8
The safety profile and tolerability of tezepelumab in the WAYPOINT trial were consistent with the known profile of the medicine.2
Regulatory applications are currently under review in the US, China, Japan and several other countries based on the WAYPOINT trial. 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. 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).
2. Lipworth, BJ, Han JK, et al. Tezepelumab in adults with severe, uncontrolled CRSwNP. N Engl J Med. 2025;392(12):1178-1188.
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 from: https://www.ncbi.nlm.nih.gov/books/NBK560746/ [Last accessed: September 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. Viskins A, et al. Multiple reasons underlaying uncontrolled disease in the majority of chronic rhinosinusitis patients. Front Allergy. 2022;13;3:1048385.
9. Tezspire (tezepelumab) US prescribing information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf. [Last accessed: September 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. [Last accessed: September 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. [Last accessed: September 2025].
