Remdesivir Approved for Pediatric Patients Ages 12 and Younger With COVID-19

The FDA has approved a supplemental New Drug Application for remdesivir (Veklury; Gilead) for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death.

This decision comes after the recent approval of remdesivir for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19. Under the expanded indication, a 3-day remdesivir treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for disease progression. For hospitalized children who do not require invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), a 5-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, of Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina, 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.”

Remdesivir is a nucleotide analog and has become a foundational treatment for hospitalized patients with COVID-19. It is a recommended treatment specifically for reducing disease progression in non-hospitalized patients at high risk of disease progression. Currently, more than half of patients hospitalized with COVID-19 in the United States are treated with remdesivir, according to the press release.

The approval is supported by results from the CARAVAN phase 2/3 single arm, open-label study, which demonstrated that remdesivir was generally well-tolerated among pediatric patients hospitalized with COVID-19. According to the study, a high proportion of participants showed clinical improvement and recovery, with data from other trials supporting remdesivir’s use in adults.

Of the 53 pediatric patients enrolled in the CARAVAN study, no new safety signals were apparent for patients treated with remdesivir. Overall, 75% and 85% of patients showed clinical improvement at day 10 and last assessment, respectively, whereas 60% and 83% were discharged by day 10 and day 30, respectively.

In the study, 38 participants experienced adverse events (AEs), with 11 (21%) experiencing serious AEs that were determined not to be study-drug related, including 3 participant deaths that were consistent with the patients’ underlying medical conditions prior to study entry or with COVID-19 disease during hospitalization.

“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,” said Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, in the press release.

REFERENCE

Veklury (Remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19. News release. Gilead; April 25, 2022. Accessed April 26, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/4/veklury-remdesivir-is-first-and-only-approved-treatment-for-pediatric-patients-under-12-years-of-age-with-covid19