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FDA Approves Remdesivir Treatment for Young Children and Babies With COVID-19

On Monday (April 25), the U.S. Food and Drug Administration (FDA) expanded ( the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with a positive SARS-CoV-2 test who are hospitalized, or not hospitalized and at a high risk of severe COVID-19.

The FDA claimed “a need for safe and effective COVID-19 treatment options for children, some of whom do not currently have a vaccination option” and cited a “similar course of COVID-19 disease in adults and pediatric patients and efficacy results from phase 3 clinical trials in adults” as reasons for the approval, which is also supported by a phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms with confirmed SARS-CoV-2 infection presenting COVID-19, where the safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults.

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