Some patients seeking treatment outside hospitals can now use the antiviral remdesivir after U.S. drug regulators late Friday expanded approval of the drug.
The Food and Drug Administration (FDA) said the expansion was supported by a study run by Gilead Sciences, which developed remdesivir, showing the drug cut the risk of hospitalization by 87 percent among people who tested positive for COVID-19.
No other research was cited by the FDA.
The study was done before the Omicron variant became dominant in the United States, though the National Institutes of Health-convened COVID-19 Treatment Guidelines Panel said recently (pdf) the drug “is expected to be active against the Omicron” strain.
The panel recommended remdesivir be made an option for non-hospitalized patients alongside the already-available monoclonal antibody treatment sotrovimab from GlaxoSmithKline.
Monoclonal antibodies require a one-time intravenous infusion, versus IV administration across three straight days for remdesivir.
Dr. David Boulware, an infectious diseases specialist at the University of Minnesota who studies COVID-19 treatments, said in a social media post that the Gilead study was small—562 people were enrolled, about half of whom received a placebo—and that a followup randomized controlled study would likely find a lower effectiveness against hospitalization.
The FDA’s move means individuals 12 or older who weigh at least 88 pounds, have tested positive for COVID-19, are not hospitalized, and are deemed at high risk for progression to severe COVID-19 can now get the drug, which was previously restricted to hospitalized patients.
The FDA also authorized the drug for children younger than 12 who weigh at least 3.5 kilograms (7.7 pounds) and meet the same criteria.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
The expanded clearance “provides FDA imprimatur on what is already happening to fill in the supply limitations of other therapeutics. So, it is a good thing,” Dr. David Wohl, a professor at the University of Carolina at Chapel Hill’s Institute of Global Health and Infectious Diseases, told The Epoch Times in an email.
Wohl, who has received funding from Gilead, has studied remdesivir and found it helped prevent death.
This is an excerpt from The Epoch Times.
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