REG - AstraZeneca PLC - Tezspire Approved in EU for CRSwNP

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RNS Number : 2958E  AstraZeneca PLC  22 October 2025

22 October 2025

Tezspire approved in the EU for chronic rhinosinusitis with nasal polyps

Approval based on WAYPOINT Phase III results demonstrating reduced nasal polyp
severity and nasal congestion, near-elimination of the need for surgery and
significantly reduced systematic corticosteroid use vs. placebo

AstraZeneca and Amgen's Tezspire (tezepelumab) has been approved in the
European Union (EU) as an add-on therapy with intranasal corticosteroids for
the treatment of adult patients with severe chronic rhinosinusitis with nasal
polyps (CRSwNP) who have not adequately responded to standard therapy
(systemic corticosteroids and/or surgery).

 

The approval by the European Commission (EC) follows the positive opinion
(https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-recommended-for-approval-in-eu-for-crswnp.html)
of the Committee for Medicinal Products for Human Use (CHMP) and was based on
positive results from the WAYPOINT
(https://www.astrazeneca.com/media-centre/press-releases/2025/positive-results-from-the-tezspire-phase-iii-waypoint-trial-highlight-rapid-and-sustained-effect-in-chronic-rhinosinusitis-with-nasal-polyps.html#:~:text=Full%20results%20from%20the%20positive,(CRSwNP)%20compared%20to%20placebo.)
Phase III trial, 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
(https://www.nejm.org/doi/full/10.1056/NEJMoa2414482) .(1-3) 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.(2,3)

 

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 challenging to treat, as it often requires repeat surgeries
and ongoing treatment with systemic corticosteroids, both of which can result
in serious side effects. Tezepelumab's approval in the EU means clinicians
have an innovative new treatment option that has shown a clinically meaningful
and significant reduction in nasal polyp size, symptom severity and the need
for surgery and systemic corticosteroid use compared to placebo."

 

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals
Business Unit, AstraZeneca, said: "In Europe, we know that nearly half of
patients with chronic rhinosinusitis with nasal polyps remain uncontrolled
despite treatment with standard of care, which is why today's approval of
Tezspire is such an important step forward in this challenging disease. This
approval broadens Tezspire's benefits beyond severe asthma and reinforces
Tezspire's innovative mechanism of action that targets thymic stromal
lymphopoietin (TSLP), uniquely addressing epithelial-driven inflammation at
its source."

 

CRSwNP affects approximately 320 million people worldwide and is a complex
disease characterised by epithelial-driven inflammation and benign polyp
growths within the nasal cavity.(4,5) 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.(5,6) People living with CRSwNP commonly experience
airflow obstruction and symptoms including congestion and an impaired sense of
smell.(5,7-9)

 

The safety profile and tolerability of Tezspire in the WAYPOINT trial was
generally consistent with the known profile of the medicine. The most
frequently reported adverse events in the trial were COVID-19, nasopharyngitis
and upper respiratory tract infection.(2)

 

Tezspire was recently approved in the US for the add-on maintenance treatment
of adult and paediatric patients aged 12 years and older with inadequately
controlled CRSwNP,(10) and regulatory applications are currently under review
in China, Japan and several other countries. Tezspire is also approved for
severe asthma in the US, EU, Japan and more than 60 countries across the
globe.(10-12)

 
Notes

 

Chronic Rhinosinusitis with Nasal Polyps

CRSwNP is a complex inflammatory disorder, characterised by persistent
inflammation of the nasal mucosa accompanied by benign growths, called nasal
polyps.(4,5) Nasal polyps 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.(7-9)

 

Epithelial dysfunction and inflammation are important characteristics of
chronic rhinosinusitis and impede the ability of the epithelium to act as a
physical and immunological barrier against the external environment.(4,13-15)
Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine that has been
implicated in shared pathophysiological processes underlying severe asthma and
CRSwNP.(14,15)

 

Current treatments for CRSwNP include intranasal and/or systemic
corticosteroids, surgery and biologics.(5,9,16-21)

 

Phase III WAYPOINT trial

WAYPOINT was a double-blind, multi-centre, randomised, placebo-controlled,
parallel group trial designed to evaluate the efficacy and safety of
tezepelumab in adults with uncontrolled CRSwNP.(2,3,22) Participants received
tezepelumab or placebo, administered via subcutaneous injection.(2,3,22) The
trial also included a post-treatment follow-up period of 12-24 weeks for
participants who completed the 52-week treatment period.(2,22)

 

The co-primary endpoints of the trial were change from baseline in total nasal
polyp size, measured by the endoscopic total Nasal Polyp Score, and change
from baseline in bi-weekly mean nasal congestion, measured by the participant
reported Nasal Congestion Score evaluated as part of the daily Nasal Polyposis
Symptom Diary.(2,22) Key secondary endpoints included loss of smell;
improvement in disease specific health-related quality of life as measured by
SinoNasal Outcome Test (SNOT-22) score; Lund-Mackay score; time to surgery
decision and/or systemic corticosteroids for nasal polyposis; time to nasal
polyposis surgery decision; time to systemic corticosteroids for nasal
polyposis; Nasal Polyposis Symptom Diary total symptom score and, in the
population with co-morbid asthma, pre-bronchodilator FEV1 at Week 52.(2,22)

 

Tezepelumab

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
inflammation associated with severe asthma, CRSwNP and other inflammatory
diseases.(14,15)

 

TSLP is released by the epithelium in response to environmental triggers
(including allergens, viruses and other airborne particles) associated with
asthma, CRSwNP, chronic obstructive pulmonary disease (COPD), eosinophilic
esophagitis (EoE) and other diseases.(15,23) Across these disease states, the
expression of TSLP is increased and correlates with disease severity.(24,25)

 

Tezspire is approved as a single-use pre-filled syringe and auto-injector for
self-administration in the US and EU.(10,11) Since 2021, over 100,000 patients
have been treated with Tezspire for severe asthma.(26)

 

Beyond CRSwNP, Tezspire is also being explored in Phase III trials in COPD and
EoE.(27,28) In October 2021, Tezspire was granted Orphan Drug Designation
(https://www.astrazeneca.com/media-centre/press-releases/2021/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html)
by the U.S. Food and Drug Administration (FDA) for the treatment of EoE.(29)

 

Amgen Collaboration

The 2012 Collaboration Agreement between Amgen and AstraZeneca has been
amended and updated over time. For Tezspire, both companies 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 agreement, Amgen and
AstraZeneca jointly commercialise Tezspire in the US. Amgen records product
sales in the US, with AZ recording its share of US profits as Collaboration
Revenue. Outside of the US, AstraZeneca records 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 (https://www.astrazeneca.com/)

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are
sold in more than 125 countries and used by millions of patients worldwide.
Please visit astrazeneca.com (https://www.astrazeneca.com/) and follow the
Company on Social Media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca/posts/?feedView=all) .

 
Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   AstraZeneca news release. Tezspire recommended for approval in the EU
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https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-recommended-for-approval-in-eu-for-crswnp.html
(https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-recommended-for-approval-in-eu-for-crswnp.html)
. Accessed October 2025.

2.   Lipworth, BJ, Han JK, et al. Tezepelumab in adults with severe,
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3.   Lipworth, BJ, Han JK, et al. Efficacy and safety of tezepelumab in
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8.   Abdalla S, et al. Prevalence of sinonasal outcome test (SNOT-22)
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(https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/e306dc06-d580-4457-b15f-9f28545ad63a/e306dc06-d580-4457-b15f-9f28545ad63a_viewable_rendition__v.pdf)
. Accessed: October 2025.

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. Accessed: October 2025.

12.  AstraZeneca news release. Tezspire approved in Japan for the treatment
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https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html
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. Accessed: October 2025.

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. Accessed: October 2025.

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. Accessed: October 2025.

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. Accessed: October 2025.

20.  Dupixent (dupilumab) Summary of Product Characteristics. Available at:
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. Accessed: October 2025.

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With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available
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(https://clinicaltrials.gov/ct2/show/NCT04851964) . Accessed: October 2025.

23.  Zhang M, et al. Hypoxia induces the production of epithelial-derived
cytokines in eosinophilic chronic rhinosinusitis with nasal polyps. Int
Immunopharmacol. 2023;121:110559.  

24.  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.

25.  Ying, S, O'Connor, B, Ratoff, J, et al. Thymic stromal lymphopoietin
expression is increased in asthmatic airways and correlates with expression of
Th2-attracting chemokines and disease severity. J Immunol 2005;174:8183-8190.

26.  AstraZeneca Data on File. 2025. REF-278452.

27.  Clinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE).
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28.  Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Patients with
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29.  AstraZeneca news release. Tezepelumab granted Orphan Drug Designation in
the US for eosinophilic esophagitis. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2021/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html
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. Accessed: October 2025.

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

 

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