The US Food and Drug Administration (FDA) on Monday said it has expanded approval for Gilead Sciences Inc.’s Veklury (remdesivir) to include pediatric patients as young as 28 days, weighing at least 3 kilograms, making Veklury “the first approved COVID-19 treatment for children less than 12 years of age.”
The drug can be administered to patients who are hospitalized with COVID-19, with mild-to-moderate symptoms, and those who are at a high risk of developing severe COVID-19, which might result in hospitalization or death, according to the FDA.
“Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19,” the FDA 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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
“This approval means that remdesivir can potentially provide meaningful clinical improvement, by reducing disease progression and helping children recover from COVID-19 more quickly,” said Amina Ahmed, MD, Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina in the United States, in a press release from Gilead, the maker of the drug. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”
“The pediatric study CARAVAN was carried out with 53 patients, who showed no apparent safety signals when treated with Veklury. Overall, 75% and 85% showed clinical improvement (≥2 point increase on the ordinal scale) at Day 10 and last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively,” according to the Gilead press release.