Only COVID-19 Treatment for Pediatric Patients Approved

California-based Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for Veklury® (remdesivir).

The approval on April 25, 2022, is for the treatment of pediatric patients 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.

Today's FDA approval follows the recent approval for Veklury 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 three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients at high risk for COVID-19 disease progression.

For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or 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, M.D., Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina, in a related press statement. 

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

Veklury inhibits the SARS-CoV-2 RNA-dependent RNA polymerase, essential for viral replication.

Veklury is contraindicated in patients who are allergic to Veklury or any of its components.

Note: Gilead's press release was edited for clarity and manually curated for mobile readers.