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Considerations and Challenges in the Remdesivir COVID‐19 Pediatric Development Program

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The US Food and Drug Administration 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,… Click to show full abstract

The US Food and Drug Administration 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 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.

Keywords: covid pediatric; challenges remdesivir; considerations challenges; pediatric development; development; remdesivir covid

Journal Title: Journal of Clinical Pharmacology
Year Published: 2022

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