EMA Recommends Approval Of AstraZeneca's COVID-19 Therapy, Evusheld

EMA's human medicines committee (CHMP) has recommended granting marketing authorization for AstraZeneca Plc's AZN Evusheld to prevent COVID-19 in adults and adolescents before potential exposure to the SARS-CoV-2 virus.

• Evusheld is made of tixagevimab and cilgavimab, two monoclonal antibodies designed to attach to the spike protein of the SARS-CoV-2 virus (the virus that causes COVID-19) at two different sites. 
• When the antibodies in Evusheld attach to the spike protein, the virus cannot enter the cells to multiply and is unable to cause COVID-19 infection.
• The CHMP evaluated data from a study in over 5,000 people showing that Evusheld, given as two injections of 150 mg tixagevimab and 150 mg cilgavimab, reduced the risk of COVID-19 infection by 77%, with the duration of protection estimated to be at least six months. 
• In the study, adults who had never had COVID-19 and had not received a COVID-19 vaccine or other preventative treatment received Evusheld or placebo. 
• Of the people given Evusheld, 0.2% (8 out of 3,441) had lab-confirmed breakthrough COVID-19 after treatment, compared with 1.0% (17 out of 1,731) on the placebo.
• Related: AstraZeneca's COVID-19 Antibody Neutralizes Omicron Sub-variants, Lab Study Shows.
• EMA will assess data in the coming weeks to evaluate whether an alternative dosing regimen could be appropriate for preventing COVID-19 resulting from emerging variants.
• Price Action: AZN shares are up 1.37% at $65.20 during the market session on the last check Thursday.