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

Gilead Inc said on Friday the U.S. Food and Drug Administration expanded the emergency use authorization of its experimental antiviral COVID-19 treatment, remdesivir, to allow its use in all hospitalized COVID-19 patients.

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The drug was authorized in May for use in patients with a severe form of the illness, after trial data showed the antiviral drug helped shorten hospital recovery time. Patients with more moderate COVID-19 were shown in studies to have modest benefit after being given the drug, according to a study published last week.

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That study found that moderately ill patients treated with the antiviral drug for up to five days had significantly higher odds of improvement in certain areas, such as whether they needed supplemental oxygen, compared to patients given standard treatment. But the importance of that benefit was uncertain, Gilead said, due to continued questions about how best to measure patient outcomes other than survival.

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The FDA said in a press release that it had concluded that remdesivir may be effective to treat the disease and the potential benefits outweigh the risks.

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(Reporting by Michael Erman in Maplewood, N.J., and Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli and Leslie Adler)

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