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Long-Acting Antibody Combination Approved to Protect Europeans From COVID-19

September 21, 2022 • 10:26 am CDT
by Gerd Altmann
(Precision Vaccinations)

U.K.-based AstraZeneca announced yesterday that Evusheld had been approved in the European Union (EU) for treating adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.

Evusheld (AZD7442) is a combination of two long-acting antibodies, tixagevimab and cilgavimab, derived from B-cells donated by convalescent patients after SARS-CoV-2 coronavirus infection.

Iskra Reic, EVP, Vaccines and Immune Therapies, AstraZeneca, commented in a press release issued on September 20, 2022, “COVID-19 remains an ongoing health concern for millions of people. Europeans and around the world, especially for those who may not be well-protected against the virus from vaccination."

"With this approval, Evusheld is now the only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe, allowing us to protect even more people from this devastating disease.” 

The recommended dose of Evusheld for treatment in Europe is 300mg of tixagevimab and 300mg of cilgavimab, administered as two separate, sequential IM injections.

Evusheld was granted marketing authorisation in the EU for pre-exposure prophylaxis of COVID-19 in a broad population of adults and adolescents earlier in 2022, and is already available in a majority of countries in Europe.

Previously, the U.S. Food and Drug Administration issued an emergency use authorization for Evusheld on December 8, 2021. Furthermore, Evusheld is being developed with support from the U.S. government.

Regarding effectiveness against Omicron variants, AstraZeneca stated, 'Evusheld has been shown to retain in vitro neutralisation of Omicron BA.5.

And real-world evidence generated to date has demonstrated significantly lower rates of symptomatic COVID-19 and/or hospitalization/death for immunocompromised patients receiving Evusheld compared to control arms of clinical trials.

This real-world evidence includes data collected while Omicron BA.5, BA.4, BA.2, BA.1, and BA.1.1 were circulating.

Additional SARS-CoV-2 antibody treatment news is posted at PrecisionVaccinations.com/Antibody.

Note: This announcement was manually translated and curated for mobile readership.

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