Express Pharma

EU recommends marketing approval for Evusheld to treat COVID-19

Recommendation based on Tackle phase-III treatment data showing reduced risk of severe COVID-19 or death

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The European Union (EU) has recommended marketing approval for AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination for treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19, AstraZeneca notified in a statement.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Tackle phase-III COVID-19 treatment 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. Evusheld treatment earlier in the disease course led to more favourable outcomes. Tackle was conducted in non-hospitalised adults with mild-to-moderate COVID-19 who were symptomatic for seven days or less. Ninety per cent of the trial participants were at high risk of progression to severe COVID-19 due to co-morbidities or age. Evusheld was generally well tolerated in the trial, the statement said.

Further, according to the statement, the recommended dose of Evusheld for treatment in the EU is 300mg of tixagevimab and 300mg of cilgavimab, administered as two separate, sequential IM injections.

Evusheld has been shown to retain in-vitro neutralisation of Omicron BA.5, which is currently the 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 statement added.

Evusheld was granted marketing authorisation in the EU for pre-exposure prophylaxis (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, concluded the statement.