The move comes months after the agency expanded the drug’s emergency use authorization to also include children below 12 years of age weighing at least 3.5 kilograms.

The Food and Drug Administration’s (FDA) decision makes the drug the first approved COVID-19 treatment for children less than 12 years of age, the agency said.

The approval is applicable to children who are hospitalized, or have mild-to-moderate disease and are at high risk of severe COVID-19.

Remdesivir is a nucleotide prodrug of an adenosine analog. It binds to the viral RNA-dependent RNA polymerase and inhibits viral replication by terminating RNA transcription prematurely. Remdesivir has demonstrated in vitro activity against SARS-CoV-2.

In a rhesus macaque model of SARS-CoV-2 infection, remdesivir treatment was initiated soon after inoculation; the remdesivir-treated animals had lower virus levels in the lungs and less lung damage than the control animals.

Remdesivir is expected to be active against the B.1.1.529 (Omicron) variant of concern.