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FDA expands authorization of remdesivir for use in some COVID-19 outpatients

FDA expands authorization of remdesivir for use in some COVID-19 outpatients
The Food and Drug Administration approved Friday Gilead's antiviral medicine remdesivir for use in certain non-hospitalized patients. File Photo by Terry Schmitt/UPI | License Photo

Jan. 22 (UPI) -- The Food and Drug Administration has expanded its authorization of the antiviral drug remdesivir to some COVID-19 outpatients.

The FDA took two actions Friday to expand the use of the antiviral drug created by Gilead Sciences biopharmaceutical company "to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease," according to a statement.

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The federal agency approved the antiviral drug for patients age 12 and older who weigh at least 88 pounds, with positive COVID-19 test results, who are not hospitalized, have mild-to-moderate symptoms and are at high risk for progression to severe symptoms, leading to hospitalization or death.

Second, it also revised the Emergency Use Authorization for the drug to include pediatric patients under age 12 weighing at least 7.7 pounds who are similarly experiencing mild-to-moderate symptoms and are at high risk of severe symptoms.

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The two actions will allow these COVID-19 outpatients to receive remdesivir through intravenous infusion for a total of three days.

While these actions provide another treatment option to reduce risk of hospitalization, the FDA said the antiviral drug "is not a substitute for vaccination."

The FDA said vaccination remains the strongest preventative measure.

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The federal agency previously granted emergency approval to two antiviral pills as treatment for COVID-19, one from Merck called Molnupiravir and another from Pfizer called Paxlovid.

"On the heels of the FDA's recent authorization of two oral antiviral drugs, todays actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant," said Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research in a statement Friday. "Today's actions provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers."

The approval of remdesivir for use in non-hospitalized patients was backed by a randomized, placebo controlled clinical trial that included 562 non-hospitalized patients with mild-to-moderate COVID-19 who were at risk for severe COVID-19, including hospitalization or death.

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Of 279 patients who received the drug, two required COVID-19-related hospitalization. Of 283 patients who received a placebo, 15 required such hospitalization. There were no deaths.

Gilead said in a statement these results show an 87% reduction in risk for COVID-19 hospitalization.

"Remdesivir has now helped to treat more than 10 million people around the world with COVID-19 and continues to play a key role in helping to reduce the burden of the pandemic," Gilead Sciences CEO and Chairman Daniel O'Day said in the statement. "Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease."

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Since the pandemic began, COVID-19 has infected over 346 million people worldwide and killed over 5.5 million, according to Johns Hopkins' global map of cases and deaths. In the United States alone, COVID-19 has infected over 70 million and killed over 864,000.

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