The Food and Drug Administration (FDA) has expanded the approval of Veklury (remdesivir for injection) to include pediatric patients who are at least 28 days old weighing at least 3kg with positive results of direct SARS-CoV-2 testing who are:
- Hospitalized, or
- Not hospitalized and have mild to moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Previously, Veklury was only approved for patients 12 years of age and older weighing at least 40kg. Under the expanded approval, a 3-day treatment course of Veklury is recommended in nonhospitalized COVID-19 pediatric patients who are at high risk for progression to severe COVID-19. A 5-day treatment course is recommended for hospitalized COVID-19 pediatric patients who do not require invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO). The recommended total treatment duration for hospitalized patients requiring invasive mechanical ventilation and/or ECMO is 10 days.
The approval was supported by data from the single-arm, open-label phase 2/3 CARAVAN study (ClinicalTrials.gov Identifier: NCT04431453), which assessed the efficacy and safety of Veklury in 53 pediatric patients (≥28 days old and weighing ≥3kg) with confirmed SARS-CoV-2 infection and COVID-19.
Results showed that 75% and 85% of patients achieved clinical improvement (at least a 2 point increase on a 7-point ordinal scale) at day 10 and at last assessment, respectively. Recovery (defined as an improvement from a baseline clinical status score of 2 through 5 to a score of 6 or 7, or an improvement from a baseline score of 6 to a score of 7) was reported for 62% of patients on day 10; time to recovery was 7 days (range, 5-16). Sixty percent of patients were discharged by day 10, while 83% were discharged by day 30.
The safety profile of Veklury in pediatric patients was similar to that seen in adults; no new safety signals were reported. The most common adverse reactions associated with treatment include nausea and increased levels of liver enzymes.
“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 COVID-19 treatment options for this population,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
Veklury for injection is supplied as a 100mg lyophilized powder in a vial that must be reconstituted and diluted prior to intravenous infusion.
- Coronavirus (COVID-19) update: FDA approves first COVID-19 treatment for young children. News release. US Food and Drug Administration. Accessed April 25, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-approves-first-covid-19-treatment-young-children
- Veklury® (remdesivir) is first and only approved treatment for pediatric patients Under 12 years of age with COVID-19. News release. Gilead Sciences, Inc. Accessed April 25, 2022. https://www.businesswire.com/news/home/20220424005048/en/Veklury%C2%AE-Remdesivir-is-First-and-Only-Approved-Treatment-for-Pediatric-Patients-Under-12-Years-of-Age-with-COVID-19
- Veklury. Package insert. Foster City, CA: Gilead Sciences, Inc; 2022. Accessed April 26, 2022. https://www.gilead.com/-/media/files/pdfs/medicines/COVID-19/veklury/veklury_pi.pdf