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.
US FDA Approves Tezspire in CRSwNP
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 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 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 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.
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. 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/. 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.
Accessed October 2025.
9. TEZSPIRE (tezepelumab) US
prescribing information. Available at: https://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. 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. 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. Accessed October 2025.
15. Xolair (omalizumab) US
prescribing information; Available at: 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. Accessed October 2025.
17. Nucala (mepolizumab) US
prescribing information; Available at: 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. Accessed October 2025.
19. Dupixent (dupilumab) US
prescribing information; Available at: 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. 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.
Accessed October 2025.
24. Clinicaltrials.gov.
Efficacy and Safety of Tezepelumab in Patients with Eosinophilic
Esophagitis (CROSSING). Available at: 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. 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.
Date: 20 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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