FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of October 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Tezspire Approved in EU for CRSwNP
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 of the Committee
for Medicinal Products for Human Use (CHMP) and was based on
positive results from the WAYPOINT 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.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 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
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 and
follow the Company on Social Media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. 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.
2. Lipworth, BJ, Han JK, et al.
Tezepelumab in adults with severe, uncontrolled
CRSwNP. N Engl J
Med. 2025;392(12):1178-1188.
3.
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).
4. Bachert C, et al. Phenotypes and
Emerging Endotypes of Chronic
Rhinosinusitis. J Allergy Clin Immunol
Pract. 2016;4(4):621-628.
5. 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/.
Accessed: October 2025.
6. Viskins A, et
al. Multiple
reasons underlaying uncontrolled disease in the majority of chronic
rhinosinusitis patients. Front
Allergy. 2022;13;3:1048385.
7. Stevens WW, et al. Chronic
Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol
Pract.
2016;4(4):565-572.
8. 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.
9. 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.
10. Tezspire (tezepelumab) US prescribing
information. Available at: 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.
11. 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.
12. 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.
13. 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.
14. Corren J, et al. Tezepelumab in adults
with uncontrolled asthma. N Engl J
Med.
2017;377:936-946.
15. Varricchi G, et al. Thymic Stromal
Lymphopoietin Isoforms, Inflammatory Disorders, and
Cancer. Front
Immunol.
2018;9:1595.
16. Xolair (omalizumab) Summary of Product
Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf.
Accessed: October 2025.
17. Xolair (omalizumab) US prescribing
information. Available at: https://www.gene.com/download/pdf/xolair_prescribing.pdf.
Accessed: October 2025.
18. Nucala (mepolizumab) Summary of Product
Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf.
Accessed: October 2025.
19. Nucala (mepolizumab) US prescribing
information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf.
Accessed: October 2025.
20. Dupixent (dupilumab) Summary of Product
Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf.
Accessed: October 2025.
21. Dupixent (dupilumab) US prescribing
information. Available at: https://www.regeneron.com/downloads/dupixent_fpi.pdf.
Accessed: October 2025.
22. 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.
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). Available
at: https://clinicaltrials.gov/ct2/show/NCT04039113.
Accessed: October 2025.
28. Clinicaltrials.gov. Efficacy and Safety
of Tezepelumab in Patients with Eosinophilic Esophagitis
(CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227.
Accessed: October 2025.
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.
Accessed: October 2025.
Matthew Bowden
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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AstraZeneca
PLC
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Date: 22 October 2025
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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