Gilead Sciences’ remdesivir received the first full approval for treating COVID-19 in children aged 28 days and older from the US Food and Drug Administration on Monday.
The announcement comes months after the FDA increased the drug’s emergency use authorisation to include youngsters under the age of 12 who weigh at least 3.5 kg.
The approval by the Food and Medicine Administration (FDA) makes the drug the first COVID-19 treatment for children under the age of 12 years old, according to the agency.
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The permission is for children who are in the hospital or who have mild-to-moderate disease and are at high risk of developing severe COVID-19.
Remdesivir is an adenosine analogue nucleotide prodrug. It binds to the viral RNA polymerase and prevents viral replication by prematurely stopping RNA transcription. Remdesivir has been shown to be effective against SARS-CoV-2 in vitro.
Remdesivir treatment was started immediately after inoculation in a rhesus macaque model of SARS-CoV-2 infection; the remdesivir-treated animals had lower viral levels in the lungs and less lung damage than the control animals.
Remdesivir is predicted to be effective against the B.1.1.529 (Omicron) strain under investigation.
