FDA approves 1st COVID-19 treatment for young children

The FDA expanded its approval of remdesivir, known by the brand name Veklury, April 25 to include infants and children 28 days and older weighing at least 7 pounds. 

The FDA first approved Gilead Sciences' therapeutic drug for use in all hospitalized COVID-19 patients 12 and older in October 2020. On Jan. 21, the agency authorized its use in nonhospitalized patients with mild to moderate COVID-19 with a high risk of their cases becoming severe. 

"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, MD, 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."


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