The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) for the pre-exposure prophylaxis of COVID-19 in certain individuals 12 years of age and older weighing at least 40kg.

Evusheld is a combination of 2 long-acting monoclonal antibodies designed to bind to distinct sites on the SARS-CoV-2 spike protein. The product is authorized for individuals who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-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 (eg, severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s).

For pre-exposure prophylaxis, the authorized dose of Evusheld is 150mg of tixagevimab and 150mg of cilgavimab administered as 2 separate consecutive intramuscular injections. Evusheld is not authorized for use in individuals for the treatment of COVID-19, or for postexposure prophylaxis of COVID-19. 

Pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. In individuals who have received a COVID-19 vaccine, Evusheld should be administered at least 2 weeks after vaccination.

The EUA was supported by primary data from the phase 3 PROVENT trial (ClinicalTrials.gov Identifier: NCT04625725), which compared the efficacy and safety of Evusheld to placebo for pre-exposure prophylaxis of COVID-19 in participants 18 years of age and older. Findings from PROVENT showed that treatment with Evusheld reduced the risk of developing symptomatic COVID-19 by 77% compared with placebo.

The most common adverse reactions reported with Evusheld were headache, fatigue, and cough. Evusheld should be used with caution in individuals with thrombocytopenia or any coagulation disorders.

Health care professionals should also consider the risks and benefits of Evusheld in individuals at high risk for cardiovascular events. In PROVENT there was a higher rate of cardiovascular serious adverse events, including myocardial infarction and cardiac failure, in participants who received Evusheld compared with placebo; a causal relationship between the treatment and these events has not been established.

Additional information on the use of Evusheld for pre-exposure prophylaxis can be found in the fact sheet.

“We now have the first antibody therapy authorized in the US to prevent COVID-19 symptoms before virus exposure, while also providing long lasting protection with a single dose,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. “Evusheld neutralizes all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant.”

The first doses are expected to be available very soon, according to the Company.

References

  1. Coronavirus (COVID-19) update: FDA authorizes new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals. News release. US Food and Drug Administration. Accessed December 8, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure
  2. Evusheld (formerly AZD7442) long-acting antibody combination authorized for emergency use in the US for pre-exposure prophylaxis (prevention) of COVID-19. News release. AstraZeneca. Accessed December 8, 2021. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/evusheld-long-acting-antibody-combination-authorised-for-emergency-use-in-the-us-for-pre-exposure-prophylaxis-prevention-of-covid-19.html.
  3. Evusheld fact sheet for health care providers. Accessed December 8, 2021. https://www.fda.gov/media/154701/download.