The U.S. Food and Drug Administration on Tuesday approved the antiviral remdesivir as the first COVID-19 treatment for young children.
The drug had so far only been available to this age group under a special FDA emergency use authorization order.
Now, doctors treating kids under 12 who are hospitalized or are at home with mild-to-moderate COVID but a high risk for severe COVID can readily prescribe Veklury (remdesivir) to their young patients.
Remdesivir had already been fully approved to treat people 12 and older.
You May Also Like
The approval was based on results from a phase 3 clinical trial for adults, the FDA said, noting that the course of the disease is similar in both adult and pediatric patients.
It is also supported by a phase 2/3 clinical study of 53 pediatric patients, the FDA said. Patients in that study had a confirmed COVID infection ranging from mild to severe and received the medication for 10 days. Results, including safety results, were similar to those already seen in adults, the agency said.
“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 an agency news release. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
Possible side effects of the drug, which can only be delivered via injection, include increased levels of liver enzymes, which may be a sign of
