The U.S. drug regulator on Monday granted the first full approval for treating COVID-19 in children aged 28 days and older to Gilead Sciences Inc’s drug remdesivir.
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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.
WHITE OAK, MD – JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images) (Photo by Sarah Silbiger/Getty Images / Getty Images)
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.
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The approval is applicable to children who are hospitalized, or have mild-to-moderate disease and are at high risk of severe COVID-19.
