EMA Recommends Approval of AstraZeneca's Evusheld for COVID-19 Pre-Exposure Prophylaxis

On March 24, the European Medicines Agency issued a statement recommending the approval of the injectable drug Evusheld for marketing, stating that it can be used for individuals with compromised immune systems or those who have severe reactions to COVID-19 vaccines.

Evusheld is a long-acting combination therapy of neutralizing antibodies, composed of two neutralizing antibodies, tixagevimab and cilgavimab, which bind to different epitopes of the SARS-CoV-2 spike protein, used for the prevention of SARS-CoV-2 infection in individuals aged 12 years and older. On December 8, 2021, Evusheld received Emergency Use Authorization (EUA) from the U.S. FDA for pre-exposure prophylaxis (PrEP) of SARS-CoV-2 infection in certain adults and adolescents (aged ≥12 years, weighing ≥40 kg), making it the only authorized therapy in the United States for COVID-19 pre-exposure prophylaxis. Unlike COVID-19 treatment drugs from Eli Lilly, Regeneron, and GlaxoSmithKline, AstraZeneca's Evusheld primarily serves as a preventive measure before exposure to the SARS-CoV-2 virus.

Recently, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized AstraZeneca's Evusheld for pre-exposure prophylaxis of COVID-19. With this approval, the therapy has become the first antibody combination treatment officially licensed in the UK for pre-exposure prevention of COVID-19.