AstraZeneca's Evusheld gets EMA panel nod to treat certain COVID-19 patients in EU
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A committee of the European Medicines Agency (EMA) recommended the approval of expanded use of 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. 16 press release.
The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) was backed by data from a phase 3 trial called TACKLE which showed one intramuscular dose of Evusheld (tixagevimab and cilgavimab, formerly AZD7442) provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo.
The European Commission, which generally follows the opinion of the CHMP, will now decide on the Evusheld's approval for this expanded use.
AZN +2.03% to $59.32 premarket Sept. 16