(RxWiki News) The US Food and Drug Administration (FDA) approved the first-ever COVID-19 treatment for infants and children.
This treatment can be given to infants as young as 28 days old who weigh at least 3 kilograms (about 7 pounds).
This new COVID-19 treatment for young children is called Veklury (remdesivir). The FDA approved it to be given to infants and children with a positive COVID test who are in the hospital or facing a high risk for severe COVID-19.
This FDA approval removes the emergency use authorization (EUA) that the FDA had previously granted to Veklury for this young age group.
Veklury had already been approved to treat certain adults and children (12 years of age and older and who weigh at least 40 kilograms).
This approval makes the drug the first-ever approved COVID-19 treatment for children younger than 12.
"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 Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release.
The FDA noted that Veklury is not a substitute for getting a COVID vaccine in children for whom vaccination and booster doses are recommended. The FDA continues to urge the public to get a COVID vaccine and booster when eligible.
This approval was supported by a few clinical trials, which included one trial of over 50 children who had mild, moderate or severe COVID-19. These children received Veklury for up to 10 days.
Possible side effects of Veklury included increased levels of liver enzymes, allergic reactions, rash, nausea, sweating or shivering.
This approval was granted to Gilead Sciences Inc.