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    Home > Active Ingredient News > Infection > FDA extends review of COVID-19 antibody cocktail REGEN-COV as pre-exposure prophylaxis

    FDA extends review of COVID-19 antibody cocktail REGEN-COV as pre-exposure prophylaxis

    • Last Update: 2022-05-16
    • Source: Internet
    • Author: User
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    Pharmaceutical company Regeneron said recently that the FDA has extended its review of the Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) by three months, with a decision on July 13


    FDA Prevention

    The FDA first granted REGEN-COV Emergency Use Authorization (EUA) in late 2020 for the treatment of mild to moderate COVID-19 in adults and high-risk pediatric patients .


    COVID-19 in children

    In November, before the surge in Omicron, Regeneron reported the results of an analysis of nearly 1,700 people who lived in the same households as those diagnosed with COVID-19 in the previous four days


    Findings from the Diagnostic Infection study showed that a single dose of REGEN-COV reduced the risk of contracting COVID-19 by 81.


    Casirivima and imdevimab are monoclonal antibodies that specifically target the SARS-CoV-2 spike protein and are designed to prevent the virus from attaching to and entering human cells


     

    Original source:

    Original source:

    https://firstwordpharma.


    https://firstwordpharma.
    com/story/5549423 https://firstwordpharma.
    com/story/5549423

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