AstraZeneca’s (AZ) Evusheld (tixagevimab and cilgavimab, formerly AZD7442) has been recommended for conditional marketing authorisation (CMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment individuals with COVID-19, the company announced.
The recommendation 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.
Iskra Reic, executive vice president, vaccines and immune therapies, AZ, said: “Evusheld has already made an important difference around the world helping prevent COVID-19 infections in vulnerable populations who can’t mount an adequate response to COVID-19 vaccination.
“This positive CHMP opinion underscores Evusheld’s potential as a COVID-19 treatment for patients at increased risk of progressing to severe disease.”
The CHMP’s recommendation 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.
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.
Moreover, AZ noted that Evusheld has been shown to retain in vitro neutralisation of Omicron BA.5, which is the current dominant SARS-CoV-2 variant in Europe.
‘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. This includes real-world evidence collected while Omicron BA.5, BA.4, BA.2, BA.1 and BA.1.1 were circulating,’ the company said in a statement.