FDA expands emergency use of Gilead’s remidasivir in hospitalized COVID-19 patients


Gilead Inc. said Friday that U.S. The Food and Drug Administration extended the validity of the emergency use of its experimental antiviral COVID-19 treatment, rimadesivir, so that it could be used in all COVID-19 patients admitted to the hospital.

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The drug was authorized in May for use in patients with severe forms of the disease, after trial data the antiviral drug helped shorten the hospital’s recovery time. A study published last week found that patients with more moderate CVD-19 had a modest benefit after being given the drug.

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The study found that typically sick patients treated with antiviral medication for five days, compared to patients receiving standard treatment, improved significantly in some areas such as whether they needed supplemental oxygen. But, the significance of that benefit was uncertain, Gilead said, due to constant questions about how to best measure non-existent patient outcomes.

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The FDA said in a press release that it concluded that remedivisor may be effective in treating the disease and that the potential benefits outweigh the risks.

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(Reporting by Michael Irman in Maplewood, NJ and Michaelica Roy; edited by Shinjini Ganguly and Leslie Adler)