The Food and Drug Administration approved Veklury — also known as the drug remdesivir — as the first COVID-19 treatment for children younger than 12 on Monday, April 25.
Now, pediatric patients 28 days and older, and weighing at least 7 pounds, can get the treatment after being hospitalized with COVID-19, according to an FDA news release.
The antiviral medicine, created by Gilead Sciences, can also be given to pediatric patients who “have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death,” the agency said.
Veklury was previously approved as a COVID-19 treatment for certain adults and children 12 and older, according to the FDA. The drug is administered through an injection.
It “directly inhibits viral replication” of the virus, according to Gilead Sciences.
“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, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
The FDA emphasized that Veklury “is not a substitute for vaccination.”
In the U.S., only the Pfizer vaccine is approved for children ages 5 and older, according to the Centers for Disease Control and Prevention.
Veklury’s approval comes after clinical trial “efficacy results” in which the drug was administered to adults, the FDA said. Additionally, it comes after a separate clinical study of 53 pediatric patients, at least 28 days old, was conducted. Veklury was given to them for up to 10 days.
The results in pediatric patients “were similar to those in adults,” according to the FDA.
After a COVID-19 infection, a Veklury treatment “should be initiated as soon as possible” for appropriate patients, Gilead Sciences notes online.
The FDA lists possible Veklury side effects as:
•Increased levels of liver enzymes
•Allergic reactions such as “changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.”
Gilead Sciences created remdesivir as part of a collaborative “antiviral development effort” with the CDC and the U.S. Army Medical Research Institute of Infectious Diseases, according to a review of the drug’s history published by the National Library of Medicine.
Remdesivir’s first reported results occurred in 2015 when it was used to treat the Ebola virus after the 2014 outbreak, the review noted.
In February 2020, a month before the COVID-19 pandemic was declared, remdesivir was used in two clinical trials in China to examine its effects against the virus, according to the review.
The drug was studied further in the U.S. and Veklury was approved by the FDA for adults and patients 12 years and older on Oct. 22, 2020, according to the agency.
At the time, the FDA said the “approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.”
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