The U.S. Food and Drug Administration (FDA) on Monday expanded the approval of the first COVID-19 treatment for very young children.
The agency “took two actions” to expand the use of Veklury, or remdesivir, to include pediatric patients who are 28 days and older and weigh at least 7 pounds who have tested positive for COVID-19. The FDA approval is applicable to children who are hospitalized or have mild-to-moderate COVID-19 symptoms and are also at high risk of severe COVID-19.
It means that Veklury is the first fully approved COVID-19 treatment for pediatric patients who are under the age of 12.
Before Monday’s decision, Veklury, made by Gilead, was only fully approved to treat certain adults and patients aged 12 and older who weigh at least 88 pounds with COVID-19, said the agency. The move also comes months after the FDA expanded the drug’s emergency use authorization to include children below 12 years of age weighing at least 7 pounds.
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