AstraZeneca COVID-19 therapy no longer authorized in U.S.
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The FDA announced Thursday that Evusheld, a COVID-19 antibody therapy developed by AstraZeneca (NASDAQ:AZN), is no longer authorized in the U.S. for emergency use due to lack of efficacy against newly dominant COVID variants.
The agency noted that these variants account for more than 90% of COVID infections in the U.S., meaning âEvusheld is not expected to provide protection against developing COVID-19 if exposed to those variants.â
The FDA decision limits the companyâs Emergency Use Authorization (EUA) to apply Evusheld in situations where the proportion of these virus strains stands at 90% or less of all current infections.
The regulator added that the decision prevents patients from developing side effects for Evusheld at a time when the treatment is effective only against less than 10% of all circulating COVID variants.
In the first nine months of 2022, AstraZeneca (AZN) added ~$1.5B in sales from Evusheld.