AstraZeneca's Evusheld gets approval in EU to treat COVID-19
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The European Commission (EC) approved AstraZeneca's (NASDAQ:AZN) Evusheld to treat people aged 12 years and older with COVIDâ19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVIDâ19.
Evusheld is already approved in the EU for preventing COVID-19 in a broad population of adults and adolescents, the company said in a Sept. 20 press release.
Last week, a panel of the European Medicines Agency (EMA) had recommended the expanded approval of Evusheld (tixagevimab and cilgavimab, formerly AZD7442).
"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," said Iskra Reic, executive vice president, Vaccines and Immune Therapies, AstraZeneca.
The EC approval was backed by data from a phase 3 trial called TACKLE which showed that one intramuscular (IM) dose of Evusheld provided protection against progression to severe COVID-19 or death from any cause, compared to placebo.
The British pharma giant said the recommended dose of Evusheld for treatment in Europe is 300mg of tixagevimab and cilgavimab, each, administered as two separate, sequential IM injections.