RNS Number : 0287O
26 January 2023
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
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.
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
Next-generation long-acting antibody Phase I/III trial
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.
Evusheld is a combination of two long-acting antibodies -
tixagevimab (AZD8895) and cilgavimab (AZD1061) - d erived 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 protein
(6) 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
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.
For details on how to contact the Investor Relations Team,
please click here . For Media contacts, click here .
1. US Food and Drug Administration Fact Sheet for Healthcare
Providers: Emergency Use Authorization for Evusheld(TM)
(Tixagevimab Co-Packaged with Cilgavimab).
https://www.fda.gov/media/154701/download [Last accessed: January
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.
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.
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.
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.
12. van Erp EA, et al. Fc-Mediated Antibody Effector Functions
During Respiratory Syncytial Virus Infection and Disease. Front
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(END) Dow Jones Newswires
January 26, 2023 13:15 ET (18:15 GMT)
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