The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.
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The U.S. Food and Drug Administration approved the first treatment for COVID-19 in young children. In this case, the agency expanded its approval of Gilead Sciences’ antiviral therapy Veklury (remdesivir) to include children 28 days of age and older who weigh at least 3 kilograms (about 7 pounds). Children who have tested positive for COVID-19, are hospitalized or are at high risk for progression to severe COVID-19, hospitalization or death are approved for the treatment.
In May 2020, Veklury became the first drug to be authorized by the FDA against COVID-19 after it met the primary endpoint in a clinical trial sponsored by the U.S. National Institute of Allergy & Infectious Diseases (NIAID). It was granted full approval in October 2020.
The drug has some controversies, mostly around perceived efficacy. In October 2020, the World Health Organization reported that the drug didn’t have any particular effect on a patient’s survival based on the WHO’s Solidarity trial. This trial evaluated remdesivir and three other drugs in 11,266 hospitalized COVID-19 patients and found none of them “substantially affected mortality” or decreased the need for ventilation.
These data appeared to contradict previous studies, and Veklury has been used in hospitalized patients ever since. It was only later that Merck’s molnupiravir and Pfizer’s Paxlovid, both antiviral therapies, were authorized for use against COVID-19. However, Veklury is an infusion that has been used throughout the disease, whereas molnupiravir and Paxlovid, which are pills, are only indicated for use within a short period after initial diagnosis.
Prior to this amendment, Veklury was only approved to treat certain adults and pediatric patients 12 years of age and older who weighed at least 50 kilograms (about 88 pounds) with COVID-19.
“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, MD, director of the FDA’s Center for Drug Evaluation and Research said. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
The FDA is quick to remind everyone that Veklury is not a substitute for vaccination, which is still the best way to prevent or decrease the severity of COVID-19.
The amended authorization was based on efficacy data from Phase III trials in adults. It is also based on Phase II/III trial data of 53 pediatric patients at least 28 days of age who weighed at least 3 kilograms with confirmed COVID-19 infection and mild, moderate or severe COVID-19. These patients received Veklury for up to 10 days. The safety and pharmacokinetic data from the Phase II/III study in children were similar to that observed in adults.
The amended treatment authorization is for a three-day regimen of Veklury for prevention in children at high risk for COVID-19 disease progression, and a five-day regimen in hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO.
“This approval means that remdesivir can potentially provide meaningful clinical improvement, by reducing disease progression and helping children recover from COVID-19 more quickly,” Dr. Amina Ahmed, MD, Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina said in a statement. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”
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