REG - AstraZeneca PLC - Update on Evusheld US EUA

AstraZenecaAnnouncement

26/01/2023 18:15

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230126:nRSZ0287Oa&default-theme=true

RNS Number : 0287O  AstraZeneca PLC  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 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
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 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
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

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
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

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDBFMRTMTATBJJ