The FDA gave approval to the use of Veklury (remdesivir) for children 28 days and older who weigh at least 3 kilograms (about 7 pounds).
The FDA said it “expanded the approval of the COVID-19 treatment Veklury to include pediatric patients 28 days of age and older weighing at least 3 kilograms with positive results of direct SARS-CoV-2 viral testing, who are hospitalized” or not hospitalized but are at “high risk for progression to severe COVID-19, including hospitalization or death.”Remdesivir is an antiviral used to treat COVID-19 that was previously only approved “to treat certain adults and pediatric patients .
The FDA said its approval “makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population.” “As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”Veklury is approved to be given as an injection.
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