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

Christian Fernsby |
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 preexposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.

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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 compromise 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.

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 neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant. We thank our clinical trial participants, the investigators, scientists, and government agencies and our colleagues at AstraZeneca who have all contributed to the development of Evusheld.”

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 and the only COVID-19 antibody delivered as an intramuscular dose (150mg tixagevimab and 150mg cilgavimab).

The primary data supporting the Evusheld EUA are from the ongoing PROVENT Phase III pre-exposure prevention trial, which showed a statistically significant reduction (77% at primary analysis, 83% at median six-month analysis) in the risk of developing symptomatic COVID-19 compared to placebo, with protection from the virus continuing for at least six months.

More follow-up is needed to establish the full duration of protection provided by Evusheld. Data from the Phase III STORM CHASER post-exposure trial and the Evusheld Phase I trial also supported the EUA. Evusheld was well-tolerated in the trials.

Studies are underway to provide information on the impact of the new Omicron variant (B.1.1.529) on Evusheld. Of the Omicron binding site substitutions relevant to Evusheld that have been tested to date in preclinical assays, none have been associated with escape from Evusheld neutralisation.

In vitro findings demonstrate Evusheld neutralises other recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.

AstraZeneca has agreed to supply the US government with 700,000 doses of Evusheld. The U.S. government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis.


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