Remdesivir: Preliminary Data and Clinical Use Versus Recommended Use.

Abstract

* Abbreviations: COVID-19 — : coronavirus disease 2019 FDA — : Food and Drug Administration Remdesivir inhibits viral replication of severe acute respiratory coronavirus 2 in vitro and has been shown to reduce time to recovery in adults with coronavirus disease 2019 (COVID-19). It is currently the only antiviral approved by the Food and Drug Administration (FDA) for the treatment of COVID-19.1–4 Although remdesivir is being used in children with COVID-19, it is not approved for patients <12 years of age. Fortunately, if treatment with remdesivir of COVID-19 meets key assumptions, the drug may qualify for the extrapolation pathway, whereby efficacy data in adults can be used to support efficacy in children. However, safety data cannot be extrapolated; population-specific safety data are needed to support FDA labeling for pediatric use. Thus, we read with anticipation the safety data on compassionate use of remdesivir in 77 children with severe COVID-19 presented by Goldman et al5 in this issue of Pediatrics . Goldman et al5 describe low rates of adverse events, including elevated liver aminotransferase levels and anemia, similar to the safety profile seen in adults receiving remdesivir. In light of these data, we will consider whether the concept of extrapolation could be used to support efficacy of remdesivir in children … Address correspondence to Danny K. Benjamin, MD, PhD, Duke Clinical Research Institute, Durham Centre, Suite 800, 300 W Morgan St., Durham, NC 27701. E-mail: danny.benjamin{at}duke.edu