For immediate release:

Today, the US Food and Drug Administration extended the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients aged 28 days and older weighing at least 3 kg (approximately 7 pounds) with positive results of direct SARS CoV-2 viral tests, which are:

  • Admitted, or
  • Not hospitalized and has mild to moderate COVID-19 and is at high risk of progression to severe COVID-19, including hospitalization or death.

This action makes Veklury the first approved COVID-19 treatment for children under 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use permit for Veklury, which previously covered this pediatric population.

Until now, Veklury was only approved to treat certain adult and pediatric patients (12 years and older weighing at least 40 kg, which is about 88 pounds) with COVID-19.

“As COVID-19 can cause serious illness in children, some of whom do not currently have a vaccination option, there is still a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, MD, Director. by the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic agent for this population demonstrates the Agency’s commitment to this need.”

Veklury is not a substitute for vaccination in persons for whom COVID-19 vaccination and booster doses are recommended. The FDA has approved two vaccines, and three vaccines are available for emergency use, to prevent COVID-19 and the serious clinical outcomes associated with COVID-19, including hospitalization and death. The FDA urges the public to be vaccinated and receive a booster when eligible. Learn more about FDA approved and approved Vaccines against covid-19.

In view of the similar course of COVID-19 disease in adult and pediatric patients, the current approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Information about the trials in adults can be found in the FDA-approved drug label for Veklury. This approval is also supported by a Phase 2/3, single-arm, open-label clinical examination of 53 pediatric patients who are at least 28 days old and weigh at least 3 kg (approximately 7 pounds) with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19. Patients in this pediatric phase 2/3 study received Veklury for up to 10 days. Safety and pharmacokinetic results from the Phase 2/3 study in pediatric subjects were similar to those in adults.

The only approved dosage form is Veklury for injection.

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

The FDA has granted approval to Gilead Sciences Inc.

Related information

###

Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The Agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.