FDA grants emergency use for AstraZeneca's Covid-19 preventative

AstraZeneca said on Thursday that its Evusheld antibody combination has been granted emergency use authorisation by the US Food and Drug Administration for the prevention of Covid-19 in adults and adolescents who are immunocompromised.

Evusheld, which is tixagevimab co-packaged with cilgavimab, can be used in people with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to Covid-19 vaccination. It can also be used in individuals for whom Covid vaccination is not recommended.

Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said: "We are proud to play a leading role in fighting the Covid-19 pandemic and, with Evusheld, we now have the first antibody therapy authorised in the US to prevent Covid-19 symptoms before virus exposure, while also providing long lasting protection with a single dose.

"Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant."

Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US for Covid-19 pre-exposure prophylaxis.