FDA OKs Gilead's remdesivir for outpatient use

Jan. 24, 2022

Gilead Sciences' Veklury (remdesivir), the antiviral drug used to treat COVID-19 in hospitalized patients, has been approved for outpatient use by the U.S FDA.

The decision, said the FDA, will provide another avenue to reduce hospitalization in high-risk patients.

In Oct. 2020, Veklury became the first COVID-19 treatment drug to be approved by the FDA after it was shown to reduce hospitalization for COVID-19 following a clinical trial with 562 non-hospitalized patients who were at high risk for a serious progression of COVID-19. There were no deaths in the trial.

Now, the drug's approval has been expanded to include use by adults and pediatric patients with mild-to-moderate COVID-19 who are at high risk of severe COVID-19 in outpatient settings including skilled nursing facilities, home healthcare settings, and outpatient facilities such as infusion centers, said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The drug will be administered via IV infusions over three consecutive days. The FDA has also expanded pediatric EUA of Veklury to include non-hospitalized pediatric patients 12 and younger who are at high risk of severe disease.

The FDA approval comes during a massive surge in COVID-19 cases as a result of the omicron variant. Although some anti-SARS-CoV-2 monoclonal antibody treatments are showing reduced efficiency with the omicron variant, Veklury targets the viral RNA polymerase. In vitro laboratory testing has shown that the drug can still be effective against the omicron variant.