EMA backs authorization of COVID-19 med Evusheld

The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a marketing authorization for Evusheld (tixagevimab and cilgavimab), developed by AstraZeneca (LSE: AZN), for the prevention of COVID-19 in adults and adolescents from 12 years of age weighing at least 40 kg before potential exposure to the SARS-CoV-2 virus.

In reaching its conclusion, the CHMP evaluated data from a study in over 5,000 people showing that Evusheld, formerly known as AZD7442, given as two injections of 150mg tixagevimab and 150mg cilgavimab, reduced the risk of COVID-19 infection by 77%, with the duration of protection from the virus 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 (a dummy injection). Of the people given Evusheld, 0.2% (eight out of 3,441) had lab-confirmed breakthrough COVID-19 in the first six months after treatment, compared with 1.0% (17 out of 1,731) of the people who received placebo.