FDA Approves Veklury for Treatment of COVID-19 in Pediatric Patients

Gilead Sciences announced on April 25, 2022 that FDA has approved a supplemental new drug application (sNDA) for Veklury (remdesivir) for the treatment of pediatric patients who are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to sever COVID-19, including hospitalization or death. Patients must also be older than 28 days and weigh at least 3 kg.

This approval follows the recent sNDA approval for Veklury for adults and adolescent patients who are at high risk of progression to severe COVID-19. For pediatric patients who are at high risk for COVID-19 disease progression, a three-day Veklury treatment regimen is recommended to help prevent hospitalization. For currently hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a five-day treatment course is recommended.

“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, NC, in a press release. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”

“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,” added Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences. “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.”

Source: Gilead Sciences