The FDA has expanded its approval of Gilead Sciences’ Veklury (remdesivir) for pediatric patients 28 days and older weighing at least 6.6 pounds who have tested positive for COVID-19 and are either hospitalized or are at high risk of developing severe COVID-19.

The expanded approval makes Veklury the first COVID-19 drug approved for children under 12 years old.

The FDA’s approval was supported by results from a phase 2/3 study in 53 pediatric patients, 75 percent of whom showed clinical improvement on Day 10 of assessment and 85 percent showed clinical improvement at the final assessment.

Veklury, a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, was first granted an Emergency Use Authorization (EUA) on May 1, 2020, in adult and older pediatric COVID-19 patients who were hospitalized with severe disease (DID, May 4, 2020).

On Aug. 28, 2020, the agency expanded the EUA to hospitalized adult and pediatric patients, regardless of the severity of their disease.

The FDA granted full approval for Veklury in October 2020 for adult and pediatric COVID-19 patients weighing at least 88 pounds who were hospitalized (DID, Oct. 23, 2020).

In January 2022, the agency expanded the approval to include nonhospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19 (DID, Jan. 25).

Under the latest expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in nonhospitalized COVID-19 younger pediatric patients who are at high risk for COVID-19 disease progression. The company also recommended a five-day Veklury treatment regimen for those pediatric patients who are hospitalized but who do not need a ventilator or extracorporeal membrane oxygenation. — Selma Khenissi