AstraZeneca’s (AZ) Evusheld (tixagevimab and cilgavimab, formerly AZD7442) has been approved by the European Commission (EC) for the treatment of individuals with COVID-19, the company announced.
The approval is specifically for the treatment of adults and adolescents – aged 12 years and older weighing at least 40kg – with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
Evusheld – a combination of two long-acting antibodies derived from B-cells donated by individuals previously infected with the COVID-19 virus – was granted marketing authorisation in the EU for the prevention of COVID-19 in a broad population of adults and adolescents earlier this year and is already available in a majority of countries in Europe.
The EC’s latest decision is based on results from a phase 3 trial which showed one intramuscular dose of Evusheld provided ‘clinically and statistically significant’ protection against progression to severe COVID-19 or death from any cause compared to placebo.
The study was conducted in non-hospitalised adults with mild-to-moderate COVID-19 who were symptomatic for seven days or less, with 90% of trial participants at high risk of progression to severe COVID-19 due to comorbidities or age.
Evusheld was generally well tolerated in the trial, the company noted, and adverse events occurred more frequently in the placebo group than the treatment group.
Moreover, AZ noted that Evusheld has been shown to retain in vitro neutralisation of Omicron BA.5 – the current dominant SARS-CoV-2 variant in Europe – and real-world evidence generated to date has demonstrated ‘significantly lower rates of symptomatic COVID-19 and/or hospitalisation/death for immunocompromised patients receiving Evusheld compared to control arms,’ the company said in a statement.
Commenting on the approval, Iskra Reic, executive vice president, vaccines and immune therapies, AZ, said: “COVID-19 remains an ongoing health concern for millions of 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 the EU is 300mg of tixagevimab and 300mg of cilgavimab, administered as two separate, sequential intramuscular injections.