FDA Grants Emergency Use Authorization for New Monoclonal Antibody Treatment

The FDA on Saturday announced an emergency use authorization for a new monoclonal antibody treatment against COVID-19.  The emergency use authorization for the new drug, called bebtelovimab, is for the treatment of “mild to moderate COVID-19 in adults and pediatric patients,” the FDA said Friday.  This includes those with a positive virus test who are […]

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  • 03/02/2023
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The FDA on Saturday announced an emergency use authorization for a new monoclonal antibody treatment against COVID-19. 

The emergency use authorization for the new drug, called bebtelovimab, is for the treatment of “mild to moderate COVID-19 in adults and pediatric patients,” the FDA said Friday. 

This includes those with a positive virus test who are at risk of progression to severe illness, including hospitalization or death, and for those whom alternative treatment options are “not accessible or clinically appropriate,” the agency said, per Just the News

Director of the FDA’s Center for Drug Evaluation and Research called the authorization “an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.” 

The FDA also said the new treatment is not a substitute for vaccination among those eligible and recommended to receive one. 

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