Back in October 2020, Gilead’s antiviral Veklury (remdesivir) became the first drug endorsed by the FDA for the treatment of COVID-19. Eighteen months later, Veklury notched another first by becoming the first COVID drug approved to treat children younger than age 12.
The nod applies to children 28 days or older who are hospitalized with COVID or those with the virus who are at risk to progressing to a severe form of the disease.
Before Monday, Veklury was approved to treat those age 12 and older. Its original authorization in October of 2020 covered hospitalized patients with severe COVID. Three months ago, the FDA expanded the authorization to include at-risk patients with mild-to-moderate COVID.
The infused drug is typically provided over three days. But for hospitalized pediatric patients who do not require mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), a five-day regimen of Veklury 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,” Amina Ahmed, M.D., of Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina, said in a release from Gilead.
The similar courses of COVID-19 in adults and children can allow pediatric approvals to be supported by efficacy results from phase 3 trials in adults, the FDA said Monday.
In addition, the approval is backed by the phase 2/3 Caravan study of 53 hospitalized pediatric patients, which produced results that were similar to those in adults. By day 10, 75% of the participants had clinical improvement with 60% discharged from the hospital.
Patrizia Cavazzoni, M.D., the director of the FDA’s Center for Drug Evaluation and Research, also highlighted the need for a treatment option, especially for very young patients who aren’t eligible for vaccines.
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective treatment options for this population,” Cavazzoni said in the FDA release.