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 3 kg 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 40 k. 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.

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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 100-mg lyophilized powder in a vial that must be reconstituted and diluted prior to intravenous infusion.

References

  1. 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
  2. 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
  3. 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

This article originally appeared on MPR

Topics:

COVID19 Infectious Disease Pediatrics Viral Infections