Evusheld FDA Approval Status
Last updated by Judith Stewart, BPharm on July 12, 2023.
FDA Approved: No
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.
UPDATE: FDA Announces Evusheld is Not Currently Authorized for Emergency Use in the U.S.
January 26, 2023 -- Evusheld is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to Evusheld. Therefore, Evusheld may not be administered for pre-exposure prophylaxis for prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency.
- 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).
- not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARSCoV-2 and
- 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
Further information
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