The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for AstraZeneca’s antibody therapy Evusheld for the pre-exposure prophylaxis or to prevent Covid-19.
Obtained from B-cells of convalescent patients following Covid-19 infection, Evusheld is a mixture of two long-acting antibodies (LAAB), tixagevimab (AZD8895) and cilgavimab (AZD1061).
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An application seeking EUA was filed by the company in October.
In June last year, AstraZeneca attained a licence to the antibodies discovered by Vanderbilt University Medical Center.
The treatment is authorised for usage in adolescents and adults 12 years and above with moderate-to-severe immune compromise, those who may not have sufficient immune response to Covid-19 vaccines and those whom inoculation is not advised.
To be administered intramuscularly, the initial doses of the therapy are anticipated to be made available in the coming days.
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By GlobalDataPeople who are infected with or were exposed to Covid-19 are not permitted to use Evusheld.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos 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.”
The EUA is based on data from the Phase III PROVENT pre-exposure prevention clinical trial of Evusheld underway.
Treatment with the LAAB combination demonstrated a statistically significant decline in symptomatic Covid-19 development risk of 77% at initial assessment and 83% during six-month analysis versus placebo.
Furthermore, data obtained from STORM CHASER, a Phase III post-exposure trial, as well as the Phase I trial of Evusheld backed the EUA.
The company committed to delivering a total of 700,000 doses of the combination treatment to the US Government.
