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Intravenous antiviral remdesivir (Veklury) is now approved for treating COVID patients in an outpatient setting, providing another therapeutic option during the Omicron surge, late on Friday.

Already approved in the hospital setting, the agency expanded remdesivir's indication to include individuals ages 12 and up (who weigh 40 kg or more) with mild to moderate COVID-19 who are at high risk of progressing to severe COVID-19.

In addition, the FDA revised the drug's emergency use authorization to include pediatric patients younger than age 12 who weigh at least 3.5 kg (but under 40 kg) at high risk of progressing to severe disease.

Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement that the expanded indications would help "respond to the surge of the Omicron variant."

High-risk adult and pediatric patients can receive the treatment "outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers," Cavazzoni added.

NIH's COVID guidelines, which were revised in late December, recommend a 3-day course of remdesivir as a third option behind the oral antiviral nirmatrelvir-ritonavir (Paxlovid) and the IV monoclonal antibody sotrovimab. They cited data from the PINETREE study, which demonstrated an 87% relative risk reduction in COVID-related hospitalizations with remdesivir.

FDA's expanded indication was based on this phase III trial as well. Among 562 non-hospitalized high-risk patients with mild to moderate COVID in the study, 0.7% required hospitalization with remdesivir versus 5.3% with placebo (P=0.008). There were no deaths in either group, the agency noted.

The FDA said that possible side effects include increased levels of liver enzymes, which could be a sign of liver injury, and "allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing," rash, nausea, sweating or shivering and swelling around the eyes and under the skin.

Gilead Sciences that the safety profile for remdesivir was similar as that of placebo, with the most common treatment-related adverse events (reported in 5% or more patients) being nausea and headache.

This 3-day course is for COVID outpatients only, Gilead added, as hospitalized patients not on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) should receive a 5-day course of the drug, and critically ill patients should receive a 10-day course.

In terms of supply, Gilead said they will "enable outpatient ordering in a tiered approach that will start with hospital outpatient departments due to their experience and familiarity with the administration of Veklury; then outpatient ordering will be available to other qualified outpatient facilities."

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