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."