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Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement

 
• By Bridget Silverman

US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.

Gilead

Special populations stand at the head of the US FDA’s long list of post-marketing priorities for Gilead Sciences, Inc.’s antiviral Veklury (remdesivir), which became the first product approved to treat COVID-19 on 22 October 2020.

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