FDA nod for new long-acting MAb combo for pre-exposure prevention of COVID-19

9 December 2021

The US Food and Drug Administration on Wednesday issued an emergency use authorization (EUA) for AstraZeneca’s (LSE: AZN) Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years and older weighing at least 40 kilograms [about 88 pounds]).

The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. The FDA says that the authorization also requires that individuals either have:

moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheetfor health care providers) or;
a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.

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