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Monoclonal antibody therapy sotrovimab receives FDA authorization for use in COVID-19

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eMediNexus    27 May 2021

The U.S. Food and Drug Administration has granted an emergency use authorization (EUA) for the use of investigational monoclonal antibody therapy sotrovimab to treat mild-to-moderate COVID-19 in adults and children, aged 12 years and above (weighing at least 40 kg), with positive findings on direct SARS-CoV-2 viral testing, having a high risk for progression to severe disease, including hospitalization or death. 

The safety and effectiveness of the investigational monoclonal antibody therapy is still being evaluated for the treatment of COVID-19. The therapy is not authorized for use in hospitalized COVID-19 patients or those who require oxygen therapy due to COVID-19. The therapy has not been found to be beneficial in patients hospitalized due to COVID-19 and it appears that monoclonal antibodies may be linked to worse outcomes when used in hospitalized patients in need of high flow oxygen or mechanical ventilation… (FDA, May 26, 2021)

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