US FDA grants EUA to AstraZeneca’s Evusheld in US for pre-exposure prophylaxis of COVID-19

Phase-III data showed at least six months of protection with one dose in high-risk participant population

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 pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available soon, the company said in a statement.

It also said that 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 40 kg 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 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 and the only COVID-19 antibody delivered as an intramuscular dose (150mg tixagevimab and 150mg cilgavimab), the statement further mentioned.

Gagandeep Singh Bedi, Managing Director, AstraZeneca India Pharma, said, “The US Food and Drug Administration’s EUA approval of AZD7442 for the prevention of COVID-19 is an important milestone, globally. We welcome this news and the opportunity it provides to support the unmet needs of high-risk and immune-compromised patients and we have already initiated engagements with the relevant health authorities in India to provide them with the latest evidence. Recent data from the phase-III Provent trial showed a robust efficacy profile and AZD7442 has so far demonstrated protection of up to six months against COVID-19 in this population.”

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 per cent at primary analysis, 83 per cent 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, according to the statement.

AstraZenecaCOVID-19 drugEvusheldUS FDA
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