EDA authorizes Evusheld long-acting antibody combination for emergency use for pre-exposure prevention of COVID-19

CAIRO - 17 Hanuary 2022: AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for pre-exposure prevention of COVID-19, has received emergency use authorisation (EUA) from the Egyptian Drug Authority (EDA).

 

The EUA follows the recent procurement agreement for Evusheld signed in December 2021 by AstraZeneca and the Egyptian Authority for Unified Procurement, Medical Supply, and Technology Management for the Ministry of Health and Population (MOHP).  The first doses of Evusheld are expected to become available in Egypt in the coming weeks.

 

Evusheld is intended to protect vulnerable populations who may be unable to mount an adequate immune response following COVID-19 vaccination due to pre-existing medical conditions such as blood cancers, patients receiving chemotherapy, those on hemodialysis and other conditions causing immunosuppression. 

 

Hatem Werdany, Country President for Egypt, AstraZeneca: “Egypt is one of the first countries to sign a procurement agreement for doses of our new long-acting antibody medicine. Evusheld will play a critical role in fighting the COVID-19 pandemic to prevent virus symptoms and provide long-lasting protection. AstraZeneca has a strong heritage in Egypt and will continue to work hand-in-hand with the government and its partners to improve patients’ lives in Egypt and around the world.”

 

The primary data supporting the Evusheld EUA are from the ongoing PROVENT trial, which demonstrated an 83% reduction in the risk of developing symptomatic COVID-19 (at the six-month analysis) with protection from the virus continuing for at least six months. Additionally, in the TACKLE outpatient treatment trial, Evusheld reduced the risk of developing severe COVID-19 or death by 88% when treated within three days in non-hospitalised patients with mild to moderate COVID-19 who had been symptomatic.

 

Two independent studies from University College Oxford and Washington University School of Medicine have also shown that Evusheld retains neutralising activity against the Omicron variant. These tests are in line with previous results from tests conducted by the US Food and Drug Administration and add to the growing body of evidence demonstrating that Evusheld retains activity against all tested SARS-CoV-2 variants of concern to date.

 

As part of its global fight against the COVID-19 pandemic, AstraZeneca has also supplied to date over 16.7 million doses of its COVID-19 vaccine to Egypt, in collaboration with its partners, to support the government’s national vaccination campaign.