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 September 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Tezspire Recommended for Approval in EU for CRSwNP
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 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 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 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
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. 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. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560746/ [Last
accessed: September 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. Viskins A, et al. Multiple
reasons underlaying uncontrolled disease in the majority of chronic
rhinosinusitis patients. Front
Allergy. 2022;13;3:1048385.
9. Tezspire (tezepelumab) US
prescribing information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf.
[Last accessed: September
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.
[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.
[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: https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf.
[Last accessed: September
2025].
15. Xolair (omalizumab) US
prescribing information. Available at: https://www.gene.com/download/pdf/xolair_prescribing.pdf.
[Last accessed: September 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.
[Last accessed: September 2025].
17. Nucala (mepolizumab) US
prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf.
[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.
[Last accessed: September 2025].
19. Dupixent (dupilumab) US
prescribing information. Available at: https://www.regeneron.com/downloads/dupixent_fpi.pdf.
[Last accessed: September 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.
[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.
[Last accessed: September 2025].
23. Clinicaltrials.gov. Efficacy and
Safety of Tezepelumab in Patients with Eosinophilic Esophagitis
(CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227?rank=1.
[Last accessed: September 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 September 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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