The U.S. Food and Drug Administration has approved the use of intravenous remdesivir to treat high-risk patients with mild-to-moderate COVID-19 in the outpatient setting, the organization announced late on Friday.
The antiviral drug, which carries the brand name Veklury, is already approved for inpatients, but now may be used for people 12 years and older (weighing at least 88 pounds) at high risk of developing severe COVID-19. Also, the FDA expanded its indication to include high-risk pediatric patients younger than 12 years old who weigh at least 7.7 pounds (but under 88).
While the FDA said remdesivir is not a substitute for vaccination and boosters, the drug will “bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” Director of the administration’s Center for Drug Evaluation and Research Patrizia Cavazzoni, MD, explained in a statement.
Those approved to receive the drug can do so outside of traditional hospital settings, including at skilled nursing facilities, home healthcare and other outpatient clinics such as infusion centers, Cavazzoni added.
The expanded approval is based on the results of a randomized, placebo-controlled clinical study performed in 563 non-hospitalized patients with mild-to-moderate COVID who were at high risk of requiring hospitalization or dying from the virus. Only 2 of the 279 individuals who received remdesivir were hospitalized for COVID compared to 15 of 283 who took a placebo.
Gilead Sciences received the revised approval for its drug and said it will immediately begin working to bolster the supply.
“Gilead will now work with distributors to make Veklury available in qualified outpatient facilities, including providing product information to non-hospital settings, to help meet the unprecedented demand for early treatment options brought on by the current COVID-19 surge,” the drug company said Friday.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.