a0287o
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 January 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on Evusheld US EUA
26 January 2023 18:15 GMT
Update on US Food and Drug Administration
Emergency Use Authorisation
of Evusheld
The US Food and Drug Administration (FDA) has stated that
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab) is
not currently authorised for Emergency Use for pre-exposure
prophylaxis (prevention) of COVID-19 in the US until further
notice, due to the sustained high frequency of circulating
SARS-CoV-2 variants that Evusheld does not retain in vitro neutralisation
against.
The FDA has notified AstraZeneca that the Agency will make a
determination about reinstating authorisation
of Evusheld if the national prevalence of resistant
variants decreases to 90% or less on a sustained basis. The US
government recommends all Evusheld product be retained and properly stored in
the event that variants susceptible to Evusheld, including those currently circulating at lower
prevalence, become more prevalent in the
future.
Based on in vitro pseudovirus assay laboratory
data, Evusheld does not neutralise Omicron subvariants
BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB and
XBB.1.5.1 The
combined proportion of COVID-19 cases caused by these subvariants
is currently greater than 90% in the US, according to the Centers
for Disease Control and Prevention (CDC) Nowcast modelling
data.2
AstraZeneca will continue to work with the FDA and other health
authorities to collect, assess and share relevant data
regarding Evusheld and SARS-CoV-2
variants. Evusheld currently remains authorised in other
countries where it is approved for COVID-19 pre-exposure
prophylaxis and treatment, including the EU and
Japan.
Next-generation long-acting antibody Phase I/III trial
underway
AstraZeneca has initiated the SUPERNOVA Phase I/III
trial to investigate the safety and efficacy of a
next-generation long-acting antibody (LAAB) in COVID-19
pre-exposure prophylaxis in an immunocompromised population. In in
vitro lab studies, the new LAAB has been shown to neutralise all
SARS-CoV-2 variants tested to date, including variants that have
proved resistant to other monoclonal antibodies.3 AstraZeneca
is aiming to make the new LAAB available in the second half of
2023, subject to trial readouts and regulatory reviews.
About 2% of the global population is considered at increased risk
of an inadequate response to COVID-19 vaccination and could benefit
from monoclonal antibodies for COVID-19
protection.4,5
Notes
Evusheld
Evusheld is a combination
of two long-acting antibodies - tixagevimab (AZD8895) and
cilgavimab (AZD1061) - derived from B-cells donated by convalescent
patients after SARS-CoV-2 infection. Discovered by Vanderbilt
University Medical Center and licensed to AstraZeneca in June
2020, the human monoclonal antibodies bind to distinct sites on the
SARS-CoV-2 spike protein6 and
were optimised by AstraZeneca with half-life extension and
reduction of Fc effector function and complement C1q
binding.7 The
half-life extension more than triples the durability of its action
compared to conventional antibodies;8-10 data
from the PROVENT Phase III trial show protection lasting six
months.11 The
reduced Fc effector function aims to minimise the risk of
antibody-dependent enhancement of disease - a phenomenon in which
virus-specific antibodies promote, rather than inhibit, infection
and/or disease.12
Evusheld is being
developed with support from the US government, including federal
funds from the Department of Health and Human
Services; Administration for Strategic Preparedness and
Response; Biomedical Advanced Research and Development Authority in
partnership with the Department of Defense; Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense,
under contract
number W911QY-21-9-0001.
Under the terms of the licensing agreement with Vanderbilt,
AstraZeneca will pay single-digit royalties on future net
sales.
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 operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. US Food and Drug Administration
Fact Sheet for Healthcare Providers: Emergency Use Authorization
for EvusheldTM (Tixagevimab
Co-Packaged with Cilgavimab).
https://www.fda.gov/media/154701/download [Last accessed: January
2023]
2.
Centers for Disease Control and Prevention CDC COVID Data Tracker:
Variant Proportions.
https://covid.cdc.gov/covid-data-tracker/#variant-proportions [Last
accessed: January 2023]
3. AstraZeneca
Data on File - REF-173560
4. Harpaz R, et al. Prevalence of
Immunosuppression Among US Adults, 2013. JAMA. 2016;316(23):2547-2548.
doi:10.1001/JAMA.2016.16477
5. AstraZeneca
Data on File - REF-129335
6. Dong J, et al. Genetic and
Structural Basis for SARS-CoV-2 Variant Neutralization by a
Two-Antibody Cocktail. Nat
Microbiol.
2021;6(10):1233-1244
7. Loo YM, et al. AZD7442 Demonstrates
Prophylactic and Therapeutic Efficacy in Non-Human Primates and
Extended Half-Life in Humans. Sci Transl
Med .
2022;14(635):eabl8124
8. Robbie GJ, et al. A Novel
Investigational Fc-Modified Humanized Monoclonal Antibody,
Motavizumab-YTE, Has an Extended Half-Life in Healthy
Adults. Antimicrob Agents
Chemother.
2013;57(12):6147-6153
9. Griffin MP, et al. Safety,
Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory
Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an
Extended Half-Life, in Healthy Adults. Antimicrob Agents
Chemother.
2017;61(3)
10. Domachowske, JB et al. Safety,
Tolerability and Pharmacokinetics of MEDI8897, an Extended
Half-Life Single-Dose Respiratory Syncytial Virus Prefusion
F-Targeting Monoclonal Antibody Administered as a Single Dose to
Healthy Preterm Infants. Pediatr Infect Dis
J.
2018;37(9):886-892
11. Levin MJ, et al. Intramuscular AZD7442
(Tixagevimab-Cilgavimab) for Prevention of Covid-19.
N Engl J
Med.
2022;386(23):2188-2200
12. van Erp EA, et al. Fc-Mediated
Antibody Effector Functions During Respiratory Syncytial Virus
Infection and Disease. Front
Immunol.
2019;10(MAR)
Adrian Kemp
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:
26 January 2023
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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