REG - AstraZeneca PLC - US FDA Approves Tezspire in CRSwNP

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RNS Number : 9274D  AstraZeneca PLC  20 October 2025

20 October 2025

Tezspire approved in the US for chronic rhinosinusitis with nasal polyps

Approval broadens indication for Tezspire to a second disease characterised by
epithelial-driven inflammation

 

AstraZeneca 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
(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, 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://www.nejm.org/doi/full/10.1056/NEJMoa2414482) .(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)

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.(12,13)

 

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

 

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.(1,2,20) Participants received
tezepelumab or placebo, administered via subcutaneous injection. The trial
also included a post-treatment follow-up period of 12-24 weeks for
participants who completed the 52-week treatment period.(1,20)

 

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.(1,20) 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.(1,20)

 

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.(13,21) Across these disease states, the
expression of TSLP is increased and correlates with disease severity.(7,11)

 

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.(22)

 

Beyond CRSwNP, Tezspire is also being explored in Phase III trials in COPD and
EoE.(23,24) 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.(25)

 

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.

 

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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/
(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
(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
(http://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
(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
(https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html)
. Accessed October 2025.

12.  Corren J, et al. Tezepelumab in adults with uncontrolled asthma. N Engl
J Med. 2017;377:936-946.

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: https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf
(https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf)
. Accessed October 2025.

15.  Xolair (omalizumab) US prescribing information; Available
at: https://www.gene.com/download/pdf/xolair_prescribing.pdf
(https://www.gene.com/download/pdf/xolair_prescribing.pdf.) .
(https://www.gene.com/download/pdf/xolair_prescribing.pdf.)  Accessed:
October 2025.

16.  Nucala (mepolizumab) Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
(https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf)
. Accessed October 2025.

17.  Nucala (mepolizumab) US prescribing information; Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf
(https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf)
. Accessed October 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
(https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf)
. Accessed October 2025.

19.  Dupixent (dupilumab) US prescribing information; Available
at: https://www.regeneron.com/downloads/dupixent_fpi.pdf
(https://www.regeneron.com/downloads/dupixent_fpi.pdf) . Accessed October
2025.

20.  Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Participants
With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available
at: https://clinicaltrials.gov/ct2/show/NCT04851964
(https://clinicaltrials.gov/ct2/show/NCT04851964) . Accessed October 2025.

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

22.  AstraZeneca Data on file. 2025. REF-278452.

23.  Clinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE)
 Online . Available at: https://clinicaltrials.gov/ct2/show/NCT04039113
(https://clinicaltrials.gov/ct2/show/NCT04039113) . Accessed October 2025.

24.  Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Patients with
Eosinophilic Esophagitis (CROSSING). Available at:
https://clinicaltrials.gov/study/NCT05583227
(https://clinicaltrials.gov/study/NCT05583227) . Accessed October 2025.

25. 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
(https://www.astrazeneca.com/media-centre/press-releases/2021/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html.)
.
(https://www.astrazeneca.com/media-centre/press-releases/2021/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html.)
Accessed October 2025.

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

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