REG - AstraZeneca PLC - Tezspire Recommended for Approval in EU for CRSwNP

AstraZenecaAnnouncement

22/09/2025 07:00

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RNS Number : 2195A  AstraZeneca PLC  22 September 2025

22 September 2025

Tezspire recommended for approval in the EU by CHMP for chronic rhinosinusitis
with nasal polyps

Recommendation based on WAYPOINT Phase III trial results showing Tezspire
reduced nasal polyp severity and nasal congestion, nearly eliminated the need
for surgery and significantly reduced systemic corticosteroid use vs. placebo

AstraZeneca 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
(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)
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
(https://bit.ly/4kmUs06) .(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)

Notes

 

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP (nasal polyps)) 

CRSwNP is a complex inflammatory disorder, characterised by persistent
inflammation of the nasal mucosa accompanied by benign growths, called nasal
polyps.(3,4) 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.(5,7)

 

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.(12,13)
Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine that has been
implicated in shared pathophysiological processes underlying severe asthma and
CRSwNP.(13)

 

Current treatments for CRSwNP include intranasal and/or systemic
corticosteroids, surgery and biologics.(4,7,14-19)

 

Phase III WAYPOINT trial

WAYPOINT is a double-blind, multi-centre, randomised, placebo-controlled,
parallel group trial designed to evaluate the efficacy and safety of
tezepelumab in adults with severe CRSwNP.(1,2,20) Participants received
tezepelumab or placebo, administered via subcutaneous injection.(1,2,20) The
trial also included a post-treatment follow-up period of 12-24 weeks for
participants who completed the 52-week treatment period.(2)(,20)

 

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)(,20) 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,)(20)

 

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.(12,13)

 

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.(13) Across these disease states, the
expression of TSLP is increased and correlates with disease severity.(7,12)

 

Tezspire is approved as a single-use pre-filled syringe and auto-injector for
self-administration in the US and EU. (9-11) Since 2021, over 100,000 patients
have been treated with Tezspire for severe asthma. (21)

 

Beyond CRSwNP, Tezspire is also being explored in Phase III trials in COPD and
EoE.(22,23) 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.

 

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 will jointly commercialise Tezspire in the US. Amgen will record
product sales in the US, with AZ recording its share of US profits as
Collaboration Revenue. Outside of the US, AstraZeneca will record 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 (http://www.astrazeneca.com/)  and follow the
Company on social media @AstraZeneca
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Contacts

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.

 

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.
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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.
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7.   Chen S, et al. Systematic literature review of the epidemiology and
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8.   Viskins A, et al. Multiple reasons underlaying uncontrolled disease in
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 http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf
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[Last accessed: September 2025].

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(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
(https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html)
. [Last accessed: September 2025].

12.  Jong-Gyun J, et al. Unraveling the Role of Epithelial Cells in the
Development of Chronic Rhinosinusitis. Int J Mol Sci. 2023;24(18):14229. doi:
10.3390/ijms241814229.

13.  Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory
Disorders, and Cancer. Front Immunol. 2018;9:1595.

14.  Xolair (omalizumab) Summary of Product Characteristics. Available at:
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(https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf)
. [Last accessed: September 2025].

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https://www.gene.com/download/pdf/xolair_prescribing.pdf
(https://www.gene.com/download/pdf/xolair_prescribing.pdf) . [Last accessed:
September 2025].

16.  Nucala (mepolizumab) Summary of Product Characteristics. Available at:
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(http://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf)
. [Last accessed: September 2025].

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. [Last accessed: September 2025].

18.  Dupixent (dupilumab) Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf
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. [Last accessed: September 2025].

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September 2025].

20.  Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Participants
With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available
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(https://clinicaltrials.gov/ct2/show/NCT04851964) . [Last accessed: September
2025].

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

22.  Clinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE).
Available at: https://clinicaltrials.gov/ct2/show/NCT04039113
(https://clinicaltrials.gov/ct2/show/NCT04039113) . [Last accessed: September
2025].

23.  Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Patients with
Eosinophilic Esophagitis (CROSSING). Available at:
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September 2025].

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

 

 

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