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Evusheld FDA Approval Status

Last updated by Judith Stewart, BPharm on Feb 25, 2022.

FDA Approved: No (Emergency Use Authorization)
Brand name: Evusheld
Generic name: tixagevimab co-packaged with cilgavimab
Dosage form: Injection
Previous Name: AZD7442
Company: AstraZeneca
Treatment for: Pre-Exposure Prophylaxis of COVID-19

Evusheld (tixagevimab co-packaged with cilgavimab) is a long-acting antibody (LAAB) combination authorized for emergency use for pre-exposure prophylaxis of COVID-19.

  • The Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) for preexposure prophylaxis for prevention of COVID-19 in persons who are:
    • not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARSCoV-2 and
      • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or
      • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s).
  • The monoclonal antibodies in Evusheld are designed to attach to the spike protein of the SARS-CoV-2 virus, to stop the virus from entering the cells to cause COVID-19 infection. Proprietary half-life extension technology increases the durability of action compared to conventional monoclonal antibodies, and the combination of LAABs is designed to reduce the risk of resistance developed by the SARS-CoV-2 virus and its variants.
  • Evusheld is the first monoclonal antibody therapy authorised by the FDA for pre-exposure prophylaxis of COVID-19. Other monoclonal antibody therapies are authorised for post-exposure prophylaxis.
  • Evusheld is derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. It is administered intramuscularly as two separate, consecutive injections.
  • Data from the Phase III PROVENT trial demonstrated protection against COVID-19 lasting for at least six months following a single administration.
  • Evusheld may cause serious adverse reactions including hypersensitivity reactions (including anaphylaxis), bleeding disorders, and cardiovascular events. Common adverse reactions include headache, fatigue, and cough.

Development timeline for Evusheld

DateArticle
Jan 26, 2023Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld
Jun  8, 2022Evusheld Significantly Prevented COVID-19 Disease Progression or Death in TACKLE Phase III Treatment Trial
Apr 20, 2022Evusheld Significantly Protected Against Symptomatic COVID-19 for at Least Six Months in PROVENT Phase III Trial in High-Risk Populations
Feb 25, 2022Update on FDA Adjustment to Evusheld Dosage Regimen in US
Dec 23, 2021Evusheld Long-Acting Antibody Combination Retains Neutralising Activity Against Omicron Variant in Studies from Oxford and Washington Universities
Dec 16, 2021Evusheld Long-Acting Antibody Combination Retains Neutralising Activity Against Omicron Variant in Independent FDA Study
Dec  8, 2021Evusheld (formerly AZD7442) Long-Acting Antibody Combination Authorised for Emergency Use in the US for Pre-Exposure Prophylaxis (Prevention) of COVID-19
Nov 18, 2021New Analyses of Two AZD7442 COVID-19 Phase III Trials in High-Risk Populations Confirm Robust Efficacy and Long-Term Prevention
Oct 11, 2021AZD7442 Reduced Risk of Developing Severe COVID-19 or Death in TACKLE Phase III Outpatient Treatment Trial
Oct  5, 2021AZD7442 Request for Emergency Use Authorization for COVID-19 Prophylaxis Filed in US
Aug 20, 2021AZD7442 PROVENT Phase III Prophylaxis Trial Met Primary Endpoint in Preventing COVID-19
Jun 15, 2021Update on AZD7442 STORM CHASER Trial in Post-Exposure Prevention of Symptomatic COVID-19
Mar 16, 2021AstraZeneca to Supply the US with up to Half a Million Additional Doses of the Potential COVID-19 Antibody Treatment AZD7442
Oct  9, 2020COVID-19 Long-Acting AntiBody (LAAB) Combination AZD7442 Rapidly Advances into Phase III Clinical Trials
Aug 25, 2020Phase I Clinical Trial Initiated for AstraZeneca's Monoclonal Antibody Combination AZD7442 for the Prevention and Treatment of COVID-19

See also

Evusheld (tixagevimab co-packaged with cilgavimab) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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