The U.S. Food and Drug Administration (FDA) on April 25 expanded approval of the first COVID-19 treatment for very young children.
The agency "took two actions" to expand the use of Veklury, or remdesivir, to include pediatric patients who are 28 days and older, weigh at least 7 pounds, and have tested positive for COVID-19. The FDA approval is applicable to children who are hospitalized or have mild-to-moderate COVID-19 symptoms and are also at high risk of severe COVID-19.
It means Veklury is the first fully approved COVID-19 treatment for pediatric patients who are under the age of 12.
Before the decision, Veklury, made by Gilead Sciences, was only fully approved to treat certain adults and patients aged 12 and older who weigh at least 88 pounds with COVID-19, the agency said. The move also comes months after the FDA expanded the drug's emergency use authorization to include children below 12 years of age weighing at least 7 pounds.
"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, who heads 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."
The agency wrote that expanding Veklury's usage for certain pediatric patients was backed by several "phase 3 clinical trials in adults." It also cited a clinical study of 53 pediatric patients who are at least 28 days old and weigh at least 7 pounds, or 3 kilograms, "with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19," according to the FDA.
"Patients in this pediatric phase 2/3 trial received Veklury for up to 10 days. The safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults," it said.
Potential remdesivir side effects include increased liver enzyme levels, which may be a sign of hepatotoxicity—or liver injury, as well as various allergic reactions such as blood pressure changes, low blood oxygen levels, shortness of breath, fever, swelling, sweating, shivering, or nausea.
Remdesivir has drawn criticism from some experts because of its cost and studies indicating it has little to no effect on COVID-19, although other research has suggested it does help COVID-19 patients, at least in some settings. The drug also has serious side effects, including kidney failure. The World Health Organization (WHO) currently recommends against its use in hospitalized patients.
"There is a conditional recommendation against the use of remdesivir. This means that there isn’t enough evidence to support its use," the WHO said at the time.