This is the first Covid-19 treatment approved for children under 12 years of age.
To be eligible for treatment, the FDA said, children must be hospitalized or have mild to moderate Covid-19 and a high risk of developing severe Covid-19, even if they are not hospitalized.
The drug, made by Gilead Sciences and sold as Veklury, had been approved to treat certain adults and patients 12 and older who weighed at least 88 pounds. It is given as an injection.
There is no Covid-19 vaccine authorized for children under the age of 5 in the United States.
The FDA’s approval of belt straps for young children is “great,” said Dr. Daniel Griffin, an instructor in clinical medicine and associate professor of research at the Department of Biochemistry and Molecular Biophysics at Columbia University.
Griffin called remdesivir a “very effective antiviral agent” to prevent the progression of Covid-19 to a more serious disease, and to reduce the risk of hospitalization or death, when given early in the course of Covid-19 infection.
“If we can extend this to children and actually give it to them in the critical time when it can make the biggest difference, we are finally really opening up more options, because these children do not have many options,” he said. “They do not have access to any of the other therapies that are limited to the age group over 12.”