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AstraZeneca’s Evusheld approved in the EU

Iskra Reic

Evusheld, a long-acting antibody combination, has been approved in the European Union (EU) for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

“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,” says Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca.

The TACKLE trial

The approval by the European Commission was based on results from the TACKLE Phase III COVID-19 treatment trial which showed one intramuscular (IM) 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. 90% of 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.

“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.”

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.

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, states AstraZeneca in its press release.

Photo of Iskra Reic: AstraZeneca