US approves Gilead’s COVID-19 treatment for children

Accordingly, medicine to treat COVID-19 Veklury (remdesivir) of Gilead approved for use in pediatric patients 28 days of age or older weighing at least 3 kg (approximately 7 pounds) who test positive for SARS-CoV-2 virus and require hospitalization; or not hospitalized and have mild to moderate COVID-19 and high risk of severe disease, including hospitalization or death.

So, antiviral drugs Veklury has become the first approved COVID-19 treatment for children under 12 years of age. With this approval, the US Food and Drug Administration (FDA) has also revoked the emergency use authorization for Veklury that was previously issued for use in this pediatric population.

Previously, Veklury was only approved to treat certain adult and pediatric COVID-19 patients (age 12 and older who weighed at least 40 kilograms, or about 88 pounds).

“Because COVID-19 can cause severe illness in children, some of whom currently don’t have an option to get vaccinated, there’s still a need for vaccinations,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. safe and effective COVID-19 treatment for this population. Today’s approval of the first COVID-19 treatment for this age group demonstrates FDA’s commitment to that need.”

Gilead’s Veklury becomes the first COVID-19 drug approved for children under 12 years of age. (Photo: Gilead Science)

Veklury is not a substitute for COVID-19 vaccination in those who are recommended to be eligible for the primary and booster doses. The FDA has approved two vaccines and three vaccines available for emergency use to prevent COVID-19 and severe clinical symptoms associated with COVID-19, including hospitalization and dead. The FDA recommends that people get vaccinated and get a booster shot when eligible. Learn more about FDA-approved and authorized COVID-19 vaccines.

Approval for the use of Veklury in certain pediatric patients was based on the results of phase 3 clinical trials in adults. Information on adult trials can be found in the FDA-approved drug label for Veklury. This approval was also supported by a phase 2/3 clinical study of 53 pediatric patients aged at least 28 days old and weighing at least 3 kg (approximately 7 pounds) with confirmed SARS-CoV infection. -2 and have mild, moderate, or severe COVID-19 infection. Patients in this phase 2/3 pediatric trial received Veklury for up to 10 days. The safety efficacy and pharmacokinetic effects from the phase 2/3 study in pediatric subjects were similar to those in adults.

The only approved dosage form of Veklury is for injection.

Possible side effects of using Veklury include increased liver enzyme levels, which can be a sign of liver damage; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, difficulty breathing, wheezing, swelling (eg, lips, around eyes, under skin), rash rash, nausea, sweating, or shivering.

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