Gilead’s Veklury Becomes First FDA-Approved COVID-19 Treatment for Children Under 12

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Recently, Gilead Sciences announced that the U.S. FDA has expanded the approval scope of Veklury (remdesivir) to include pediatric patients aged 28 days and above, weighing at least 3 kilograms, with COVID-19. This approval covers patients hospitalized due to COVID-19 as well as those with mild to moderate COVID-19 who are at high risk of progressing to severe COVID-19 (including hospitalization or death).

It is claimed that Veklury is the first and only drug approved for treating pediatric patients under 12 years old with COVID-19. In May 2020, Veklury was granted Emergency Use Authorization (EUA) by the U.S. FDA, becoming the first drug in the United States to treat COVID-19. In October of the same year, Veklury received full approval from the FDA.

Prior to this expanded approval, Veklury was approved for the treatment of adult and pediatric patients with COVID-19 aged ≥12 years and weighing ≥40 kg, including both hospitalized and non-hospitalized patients.

It is worth noting that there are currently some controversies surrounding the efficacy of Veklury. In October 2020, the World Health Organization (WHO) reported that, according to its Solidarity trial, Veklury did not have any particular impact on patient survival. The trial evaluated Veklury and three other drugs in 11,266 hospitalized COVID-19 patients and found that none of the drugs "substantially affected mortality" or reduced the need for ventilation.

These data seem to contradict previous studies. Since then, Veklury has been used for hospitalized patients. It wasn't until later that two other antiviral therapies — Merck's molnupiravir and Pfizer's Paxlovid — were also authorized to treat COVID-19. However, Veklury is an intravenous infusion drug used throughout the disease course, while molnupiravir and Paxlovid are oral medications only suitable for short-term use shortly after initial diagnosis.

However, the FDA also reminded that Veklury is not a substitute for vaccination, and vaccination remains the best way to prevent or reduce the risk of COVID-19.

This expanded approval is based on efficacy data from a Phase 3 clinical trial in adults, as well as data from the CARAVAN Phase 2/3 single-arm open-label study. The CARAVAN study included 53 pediatric patients aged ≥28 days, weighing ≥3 kilograms, with confirmed COVID-19 infection and mild/moderate/severe disease, who received Veklury treatment.

Data show that the safety and pharmacokinetic data of Veklury in this study are consistent with those observed in adult clinical trials, and a high proportion of pediatric patients achieved clinical improvement and recovery after treatment. Specifically, 75% and 85% of patients showed clinical improvement on Day 10 and at the final assessment, respectively; 60% and 83% of patients were discharged from the hospital on Day 10 and Day 30, respectively.

Reference Source: Gilead’s Veklury Becomes First FDA-Approved COVID-19 Treatment for Young Children