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

 
• By Bridget Silverman
  
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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 impact and possible lasting implications for the biopharma and medtech industry.

But the agency’s first principles were also on display when the review team determined that the lack of a mortality...

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