J Clin Pharmacol . Considerations and Challenges in the Remdesivir Covid-19 Pediatric Development Program

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J Clin Pharmacol


. 2022 Sep 23.
doi: 10.1002/jcph.2158. Online ahead of print.
Considerations and Challenges in the Remdesivir Covid-19 Pediatric Development Program


Kirk Chan-Tack ¹ , Mario Sampson ² , Justin Earp ² , Vikram Arya ² , Lynne Yao ³ , John Alexander ³ , Ethan Hausman ³ , Yodit Belew ¹ , Debra Birnkrant ¹ , Kimberly Struble ¹



Affiliations

• PMID: 36149807
• DOI: 10.1002/jcph.2158

Abstract

The Food and Drug Administration (FDA) is committed to the development of effective antiviral regimens for pediatric patients with coronavirus disease 2019 (COVID-19), including infants and neonates. On April 25, 2022, the approved indication of remdesivir (RDV) was expanded to include pediatric patients 28 days and older and weighing at least 3 kg with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral 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. Given the similar course of COVID-19 in adults and pediatric patients, the approval of RDV for use in pediatric patients is supported by the safety and efficacy data from adequate and well-controlled Phase 3 trials in adults and adolescents; and by the safety and pharmacokinetic (PK) data from a single-arm, open-label, Phase 2/3 pediatric clinical trial of 53 pediatric patients at least 28 days of age and weighing at least 3 kg with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19. At the time of the April 25, 2022 approval action, FDA also revoked the emergency use authorization (EUA) for RDV that previously covered this pediatric population. This article summarizes key issues and regulatory considerations involved in the RDV COVID-19 pediatric development program, including the evolution of the EUA issued for RDV as results from registrational studies became available, and discusses lessons learned. This article is protected by copyright. All rights reserved.

Keywords: COVID-19; antiviral; pediatrics; physiologically-based pharmacokinetic modeling.