The Food and Drug Administration has expanded its authorization of Veklury (remdesivir) for use outside of the hospital setting, including skilled nursing facilities.
Remdesivir, fully approved in October 2020 as the first COVID-19 drug, now can be used in adult and pediatric patients with mild-to moderate COVID-19 illness at high risk of progressing to severe disease, the agency announced Friday. The drug, which is administered intravenously via infusion, previously was approved only for severely ill, already hospitalized patients.
The FDA said it took the action in response to the omicron surge, with the goal of increasing the availability of COVID-19 treatments thought to neutralize the omicron variant. In a recent small clinical trial of non-hospitalized patients, the drug cut the risk of severe COVID-19 by 87%, developer Gilead announced last week.
Along with newly authorized COVID-19 antiviral pills, remdesivir may provide more treatment choices for long-term care clinicians and their patients, who have faced the loss of two gold-standard monoclonal antibody treatments rendered ineffective by the omicron variant.
Although further testing is being conducted, the drug is expected to be active against all dominant circulating SARS-CoV-2 variants to date, FDA has said.
“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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research in an accompanying statement.
“Today’s actions provide adults and pediatric patients … 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,” she said.
