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 March 2022
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.
Evusheld
approved in the EU for COVID-19
28 March 2022 07:00 BST
Evusheld long-acting antibody combination approved in
the EU for
pre-exposure prophylaxis (prevention) of COVID-19 in a broad
population
Evusheld significantly reduced the risk of developing symptomatic
COVID-19 in PROVENT Phase III trial, with protection lasting at
least six months
Evusheld retains neutralising activity against the Omicron BA.2
subvariant, now the dominant strain in Europe
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a
long-acting antibody combination, has been granted marketing
authorisation in the European Union (EU) for the pre-exposure
prophylaxis (prevention) of COVID-19 in a broad population of
adults and adolescents aged 12 years and older weighing at least 40
kg.
The approval by the European Commission was based on results from
the Evusheld clinical
development programme, including data from the PROVENT Phase III pre-exposure
prophylaxis trial which showed a 77% reduction in the risk of
developing symptomatic COVID-19 compared to placebo at the primary
analysis and an 83% reduction at a six-month median analysis, with
protection from the virus lasting at least six
months.1-3 Evusheld was
generally well-tolerated in the trial.1-3
Christoph D. Spinner, MD, Consulting Physician Infectious Diseases
and Pandemic Officer at the University Hospital Rechts der Isar and
adjunct teaching professor at the Technical University of Munich,
Munich, Germany, said: "Increasing COVID-19 cases, driven by the
highly-transmissible BA.2 subvariant, and withdrawal of several
pandemic public health measures make it important to protect
vulnerable populations, such as the immunocompromised, from
SARS-CoV-2 infection. The authorisation of Evusheld for a broad population will allow health
authorities in the EU to identify the populations who are most
at-risk and need additional protection."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, AstraZeneca, said: "The EU approval represents an
important milestone in our efforts to help prevent COVID-19, and we
will continue to work with governments across Europe to
make Evusheld available as quickly as
possible. Evusheld has the potential to provide long-lasting
protection against COVID-19 for a broad population of individuals,
including those who aren't adequately protected by a COVID-19
vaccine, as well as those at increased risk of
exposure."
The recommended dose of Evusheld in Europe is 150mg of tixagevimab and 150mg
of cilgavimab, administered as two separate sequential
intramuscular (IM) injections.
There is a growing body of evidence from multiple independent in
vitro and in vivo (animal model) studies supporting the potential
of Evusheld to protect against the BA.1, BA.1.1 and BA.2
Omicron SARS-CoV-2 subvariants in circulation around the
world.4-6 New data from
Washington University School of Medicine
demonstrated Evusheld retained potent neutralising activity
against the emerging and highly transmissible BA.2 subvariant,
which is the dominant strain in many European countries and
currently accounts for over 60% of COVID-19 infections in
Europe.6,7 This
study also showed Evusheld reduced viral burden and limited
inflammation in the lungs (in vivo) across all Omicron
variants.6
Evusheld is authorised for
emergency use for pre-exposure prophylaxis of COVID-19 in the US
and has been granted conditional marketing authorisation by the
Medicines and Healthcare products Regulatory Agency (MHRA) in Great
Britain for pre-exposure prophylaxis of COVID-19. Additionally,
there are a number of countries across Europe that have agreements
in place to provide Evusheld.
People who are not adequately protected by a COVID-19 vaccine may
particularly benefit from pre-exposure prophylaxis
with Evusheld.8-12 This
population includes about three million people in the EU who are
immunocompromised such as people with cancer or transplant patients
or anyone taking immunosuppressive medicines.13 People
at increased risk of exposure to the SARS-CoV-2 virus could also
benefit from protection with Evusheld.14
Evusheld is the only
long-acting antibody combination with positive Phase III data in
the prevention and treatment of COVID-19.2,15 AstraZeneca
is progressing with filings around the globe for potential
emergency use authorisation or marketing approval
of Evusheld in both COVID-19 prophylaxis and
treatment.
Notes
Evusheld
Evusheld, formerly known as
AZD7442, 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 protein16 and
were optimised by AstraZeneca with half-life extension and
reduction of Fc effector function. The half-life extension more
than triples the durability of its action compared to conventional
antibodies;17-19 data
from the PROVENT Phase III trial show protection lasting at least
six months.1,3 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.20
Evusheld has been granted
marketing authorisation in the European Union and Great Britain for
pre-exposure prophylaxis (prevention) of COVID-19. In the United
States, Evusheld is authorised for emergency use for
pre-exposure prophylaxis of COVID-19 in people with moderate to
severe immune compromise due to a medical condition or
immunosuppressive medications and who may not mount an adequate
immune response to COVID-19 vaccination, as well as those
individuals for whom COVID-19 vaccination is not recommended due to
a history of severe adverse reaction to a COVID-19
vaccine. This
population includes people with blood cancers or other cancers
being treated with chemotherapy, and those taking medications after
an organ transplant or who are taking immunosuppressive drugs for
conditions including multiple sclerosis and rheumatoid
arthritis.1 It
is also authorised for use and being supplied in several other
countries around the world.
The primary data supporting the Evusheld authorisations are from the
ongoing PROVENT Phase III
pre-exposure prevention trial, which showed a statistically significant
reduction in the risk of developing symptomatic COVID-19 compared
to placebo, with protection from the virus continuing for at least
six months (77% at primary analysis [8/3441
(0.2%) Evusheld arm, 17/1731 (1.0%) placebo arm]; 83% at
median six month analysis [11/3441 (0.3%) Evusheld arm, 31/1731 (1.8%) placebo
arm]).1-3 Follow-up
is ongoing to establish the full duration of protection provided
by Evusheld.
In October 2021, AstraZeneca announced positive high-level results
from the TACKLE Phase III
outpatient treatment trial in which a 600mg IM dose
of Evusheld was generally well-tolerated. AstraZeneca is
discussing the TACKLE mild-to-moderate COVID-19 treatment data with
health authorities.
Evusheld was generally
well-tolerated in the trials.
Evusheld is being
developed with support from the US government, including federal
funds from the Department of Health and Human Services; Office of
the Assistant Secretary for 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 No.
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). Available
at: https://www.fda.gov/media/154701/download [Last
accessed March 2022].
2.
AstraZeneca news release. AZD7442
PROVENT Phase III prophylaxis trial met primary endpoint in
preventing COVID-19. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html [Last
accessed: March 2022].
3.
AstraZeneca news release. New
analyses of two AZD7442 COVID-19 trials in high-risk populations
confirm robust efficacy and long-term prevention. Available
at: https://www.astrazeneca.com/media-centre/press-releases/2021/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html.
[Last accessed: March 2022]
4.
Dejnirattisai W, et al. SARS-CoV-2
Omicron-B.1.1.529 leads to widespread escape from neutralizing
antibody responses. Cell. 2022;185(3):467-484.e15.
5.
VanBlargan LA, et al. An infectious
SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by
therapeutic monoclonal antibodies. Nature
Medicine. 2022;
28:490-495.
6.
Case, J et al. Resilience of S309
and AZD7442 monoclonal antibody treatments against infection by
SARS-CoV-2 Omicron lineage strains. Available
at: https://www.biorxiv.org/content/10.1101/2022.03.17.484787v1 [Last
accessed March 2022].
7.
COVID CG. (2022). GISAID. Available
at: https://covidcg.org/?groupKey=lineage®ion=Europe&residueCoordinates=1%2C1274&selectedGene=S&tab=group [Last
accessed: March 2022].
8.
Centers for Disease Control and
Prevention. Altered Immunocompetence. General Best Practice
Guideline for Immunization: Best Practices Guidance of the Advisory
Committee on Immunization Practices. Available
at: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html [Last
accessed: March 2022]
9.
Boyarsky BJ, et al. Immunogenicity of a single
dose of SARS-CoV-2 messenger RNA vaccine in solid organ transplant
recipients. JAMA. 2021; 325
(17):1784-1786.
10.
Rabinowich L, et al. Low immunogenicity to
SARS-CoV-2 vaccination among liver transplant
recipients. J Hepatol. 2021; 75(2):435-438.
11.
Deepak
P, et al. Glucocorticoids and B cell depleting agents substantially
impair immunogenicity of mRNA vaccines to SARS-CoV-2. medRxiv
[Preprint]. 2021 Apr 9:2021.04.05.21254656. doi:
10.1101/2021.04.05.21254656.
12.
Simon D, et al. SARS-CoV-2 vaccination responses
in untreated, conventionally treated and anticytokine-treated
patients with immune-mediated inflammatory
diseases. Ann Rheum
Dis. 2021; 80(10):1312-1316.
13.
AstraZeneca
Data on File.
14.
Centers of Disease Control and
Prevention. Risk Factors of Exposure to COVID-19: Racial and Ethnic
Health Disparities. 2020. Available from: https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/increased-risk-exposure.html.
[Last accessed: March 2022].
15.
AstraZeneca news
release. Evusheld reduced
risk of developing severe COVID-19 or death in TACKLE Phase III
outpatient treatment trial. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/Evusheld-phiii-trial-positive-in-covid-outpatients.html.
[Last accessed: March 2022].
16.
Dong J, et al. Genetic and structural basis for
recognition of SARS-CoV-2 spike protein by a two-antibody
cocktail. bioRxiv. 2021; doi:
10.1101/2021.01.27.428529.
17.
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):
6147-53.
18.
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):
e01714-16.
19.
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.
20.
van Erp EA, et al. Fc-mediated antibody
effector functions during respiratory syncytial virus infection and
disease. Front
Immunol. 2019; 10:
548.
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:
28 March 2022
|
|
By: /s/
Adrian Kemp
|
|
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Name:
Adrian Kemp
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Title:
Company Secretary
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