AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the prevention of Covid-19, with first doses are expected to become available very soon.

The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of Covid-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune-compromised due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to Covid-19 vaccination, as well as those individuals for whom Covid-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.

Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the PROVENT trial, said: “Millions of people in the US and around the world remain at serious risk for Covid-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine. I am excited to offer my patients Evusheld as an easily-administered new option that provides long-lasting protection that could help them return to their everyday lives.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, 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 is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19 and the only Covid-19 antibody delivered as an intramuscular dose (150mg tixagevimab and 150mg cilgavimab).