The US Food and Drug Administration announced Monday that it has expanded approval of the Covid-19 drug remdesivir to treat patients as young as 28 days and weighing about 7 pounds.
This is the first Covid-19 treatment approved for children younger than 12.
To be eligible for treatment, the FDA said, children must be hospitalized or have mild to moderate Covid-19 and high risk for progressing to 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’s given as an injection.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
There is no Covid-19 vaccine authorized for children younger than 5 in the United States.
The FDA’s approval of remdesivir for young children is “great,” said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.
Griffin called remdesivir a “very effective antiviral” at preventing the progression of Covid-19 to a more severe illness, lowering the risk of hospitalization or death, when given early in the course of Covid-19 infection.
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“More recently, the results have come out – it was a really landmark paper published in the New England Journal of Medicine – showing that if you give remdesivir in the first five days, during the acute viral phase, before you wait for the door to close, you could prevent progression by almost 90%. It was 87% in that study. So remdesivir actually can be a very effective antiviral if you give it at the right time in the right patient,” Griffin said Monday.
“If we can extend this down to children and actually give it to them during the critical time when it can make the biggest difference, finally, we’re really opening up more options, because these kids don’t have a lot of options,” he said. “They don’t have access to some of the other therapies that are restricted to that over-12 age group.”