The United States Food and Drug Administration (FDA) has approved the first treatment for COVID-19 for the pediatric population in the United States. age group known as “early childhood”. The use of remdesivir (commercially called Veklury) is guaranteed to treat”pediatric patients aged 28 days and older who weigh at least 3 kilograms”. As they pointed out, it is intended for people hospitalized or non-hospitalized patients with mild to moderate symptoms, but who are at high risk of progression to severe or critical symptoms or even death.
As the US agency itself reported, Veklury (remdesivir) treatment approval for COVID-19 ‘expanded to include pediatric patients’thanks to the results obtained by the drug during a “Phase 2/3, open-label, single-arm clinical studywhich included 53 pediatric patients at least 28 days old and weighing at least 3 kilograms (about 7 pounds) with confirmed SARS-CoV-2 infection.
As the North American entity points out, the use of remdesivir is intended for people from 28 days or less than three kilograms who are hospitalized or non-hospitalized and who have a mild to moderate condition, but who are at risk. evolution towards serious or critical, even death (Getty Images)
who, moreover, had mild, moderate or severe symptoms of COVID-19. “Patients in this Phase 2/3 pediatric trial received Veklury for up to 10 days,” the FDA said, noting that “the safety and pharmacokinetic results of the Phase 2/3 study in pediatric subjects were similar to those of adults”, which is why “approval was granted to Gilead Sciences Inc.”.
In this way, Remdesivir Positioned as First COVID-19 Treatment Approved by U.S. Regulator for Children Under 12. “As a result of today’s approval action, the agency also revoked Veklury’s emergency use authorization that previously covered this pediatric population,” they explained. It should be noted that Veklury has only been approved to “treat certain adult and pediatric patients (aged 12 years and older and weighing at least 40 kilograms, approximately 88 pounds)”, while “the only approved dosage form is for injection”.
FDA has expanded approval of COVID-19 treatment Veklury (remdesivir) to include pediatric patients, they said in a statement REUTERS/Andrew Kelly/File Photo
Patricia Cavazzonidirector of the FDA’s Center for Drug Evaluation and Research, assured that “Because COVID-19 can cause serious illness in children, some of whom currently have no vaccination option, there is still a need for COVID-19 treatment options safe and effective for this population”.
The U.S. official also emphasized that “today’s approval of the first COVID-19 therapy for this population demonstrates the agency’s commitment to this need.” In any case, the FDA pointed out that this drug “does not replace vaccination in people for whom vaccination against COVID-19 and booster doses are recommended”. “The FDA is urging the public to get vaccinated and receive a booster when eligible. Learn more about approved and licensed COVID-19 vaccines.
“The safety and pharmacokinetic results of the Phase 2/3 study in pediatric subjects were similar to those in adults,” they said of the FDA and clarified that, for this reason, “approval has been granted to Gilead Sciences Inc.” REUTERS/Mike Blake -/File Photo
“Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in some pediatric patients is supported by efficacy results from Phase 3 clinical trials in adults .“, they pointed out from the North American entity in a press release published in the last hours.
It should be noted that, in addition, the FDA has listed the possible side effects the use of remdesivir, including: high levels of liver enzymes (which can be a sign of liver damage); and allergic reactions (which may include changes in blood pressure and heart rate, low level of oxygen in the blood, fever, shortness of breath, wheezing, swelling, rash, nausea, sweats or chills).
Robert L. Gottlieb, one of the principal investigators of the published clinical trials of remdesivir in the NEJM, said that “against COVID-19, vaccines are the primary route, while therapies like remdesivir are the secondary route”, given that this drug is already available for use in more than 50 countries around the world, including Argentina.