Injectable COVID-19 Treatment Approved for Infants
The U.S. Food and Drug Administration (FDA) today announced the expanded approval of Veklury® (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms with positive results of direct SARS-CoV-2 viral testing.
This FDA action makes Veklury the first approved injectable COVID-19 treatment for children less than 12 years of age.
Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients at high risk for COVID-19 disease progression.
For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a 5-day treatment course is recommended.
Before April 25, 2022, California-based Gilead Sciences Inc.’s Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older) weighing at least 40 kilograms) with COVID-19.
Gilead’s Veklury (remdesivir, DESREM, Redyx) is a nucleotide analog with broad-spectrum antiviral activity. Veklury inhibits the SARS-CoV-2 RNA-dependent RNA polymerase, which is essential for viral replication, says the Company.
As of April 21, 2022, the U.S. NIH's OpenData Portal compiled a database of in vitro therapeutic activity against SARS-CoV-2 variants from a prioritized set of publications (both preprints and peer-reviewed articles), reflecting Veklury's current effectiveness against SARS-CoV-2 variants, including Omicron.
Given the similar course of COVID-19 disease in adults and pediatric patients, today’s FDA approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults.
Information on the trials in adults can be found in the FDA-approved drug labeling for Veklury. The only approved dosage form is Veklury for injection.
This approval is also supported by a phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms (about 7 pounds) with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19.
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.
Possible side effects of using Veklury include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering, ays the FDA.
“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,” commented Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a related FDA press statement issued on April 25, 2022.
“Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population.
“The expanded indication for Veklury for the treatment of children is a testament to the safety, tolerability, and efficacy profile of this therapy, which has remained the foundational antiviral for COVID-19 treatment,” said Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences, in a press release.
“Effective and tolerable options for children require our best science and a dedicated focus.”
“With the recent opening of our Gilead Pediatric Center of Excellence in Dublin, which is responsible for coordinating pediatric clinical trials for treatments for HIV, hepatitis B, and COVID-19, we will continue our research to help address unmet treatment needs for children.”
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