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    Home > Active Ingredient News > Infection > The FDA extended Redsiway's emergency use authorization to all COVID-19 inpatients.

    The FDA extended Redsiway's emergency use authorization to all COVID-19 inpatients.

    • Last Update: 2020-09-19
    • Source: Internet
    • Author: User
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    The FDA has expanded the existing Emergency Use Authorization (EUA) at Gilead Sciences Veklury to treat all suspected or laboratory-confirmed COVID-19 hospitalized patients regardless of the severity of the disease.
    preliminary results from the Phase III ACTT trial showed that the average recovery time in patients in the Redsiway group was reduced by four days, and Redsiway was approved by the FDA in May for use in patients with severe COVID-19.
    , chief medical officer of Gilead, commented: "The expanded mandate allows doctors to use Redsyway more widely.
    As we learn more and more about COVID-19, we further confirm Veklury's efficacy and safety."
    addition to the ACTT trial, another study, SIMPLE, found significant clinical improvement on the 11th day in patients with moderate COVID-19 pneumonia who received Veklury's five-day course of treatment plus standard care.
    , there was no significant difference between the chances of improvement in the 10-day course of treatment and standard care.
    results of the SIMPLE study were recently published in JAMA.
    FDA concluded that Veklury's known and potential benefits outweighed the potential risks, and the FDA has reason to believe that Veklury is effective for all COVID-19 hospitalized patients.
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