US Regulators Clear Remdesivir for COVID-19 Outpatient Use

US Regulators Clear Remdesivir for COVID-19 Outpatient Use
A vial of Gilead Sciences' remdesivir in Belgium in a file image. (Dirk Vaem/Belga/AFP via Getty Images)
Zachary Stieber

Some nonhospitalized patients seeking treatment for COVID-19 can now use the antiviral remdesivir after U.S. drug regulators on Jan. 21 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 of the CCP (Chinese Communist Party) virus became dominant in the United States, although 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 nonhospitalized 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 follow-up randomized controlled study would likely find a lower effectiveness against hospitalization.

Remdesivir also didn’t reduce the viral load in patients, unlike COVID-19 pills from Pfizer and Merck, two other treatment options, he noted.

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 North 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.

Additional studies have also shown “remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease,” Gilead CEO Daniel O'Day said in a statement.

On the other hand, some research on remdesivir, the earliest drug approved against COVID-19 in the United States, has found mixed results. For instance, a study published in The Lancet last year found no clinical benefit among severely ill patients who were admitted to hospitals.
Additionally, several studies have concluded kidney disorders are one of the side effects from the drug, and remdesivir’s label (pdf) states that kidney problems were observed in testing on animals.

People who are planning to get the medication, also known as Veklury, should tell their health care provider if they have kidney or liver problems before receiving it, according to the label.

Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers U.S. and world news. Contact Zachary at [email protected]
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