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Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study

 
• By Bridget Silverman

US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.

Gilead sign at headquarters. Gilead Sciences announced plans to test a treatment for COVID-19, disease caused by growing coronavirus outbreak - Foster City, California, USA - 2020
• Source: Michael Vi / Shutterstock

The COVID-19 pandemic has highlighted the agency’s regulatory flexibility and ability to adapt to emerging outside data, especially in the review of the only COVID-19 therapy to receive full FDA approval, Gilead Sciences, Inc.’s Veklury (remdesivir).

Pandemic Perspectives

One year on from the World Health Organization declaring COVID-19 a global pandemic on 11 March 2020, editors across Informa Pharma Intelligence publications are taking a closer look at its

But the agency’s first principles were also on display when the review team determined that the lack of a mortality benefit seen in a large simple trial sponsored by the World Health Organization was not sufficient to undermine the agency’s verdict for approval on the basis of a “statistically reliable” effect on a

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