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FDA expands use of COVID-19 drug veklury for mild to moderate cases

Formerly only used for patients hospitalized with COVID-19, the Gilead Sciences Inc. drug veklury – also known as remdesivir – was expanded by order of the U.S. Food and Drug Administration (FDA) last week to include treatment for mild to moderate cases as well.

Both non-hospitalized adults and pediatric patients are eligible for the drug, although it is not a substitute for COVID-19 vaccination. Instead, those patients with positive results of direct SARS-CoV-2 viral testing, with at least mild to moderate cases and the risk of progressing to the more severe effects of COVID-19, may be given veklury. Further, the FDA reduced the weight requirements to expand availability among pediatric patients. Those who weigh at least 3.5 kilograms and less than 40 kilograms can also utilize the drug.

“On the heels of the FDA’s recent authorization of two oral antiviral drugs, today’s actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said. “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.”

For the eligible, veklury is distributed through intravenous infusion over a max of three days, with exact doses adjusted based on body weight.

Side effects may include indication of possible liver injury through increased liver enzyme levels, as well as allergic reactions, which could lead to increases in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.

Chris Galford

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