With studies showing questionable efficacy, why did Gilead’s remdesivir become the first FDA-approved COVID treatment?

remdesivir approved fda corona e d ba fill x c
Credit: Ahmed Gomaa/SIPA

On 8 October, [Gilead] inked an agreement to supply the European Union with its drug remdesivir as a treatment for COVID-19—a deal potentially worth more than $1 billion. Two weeks later, on 22 October, the U.S. Food and Drug Administration (FDA) approved remdesivir for use against the pandemic coronavirus SARS-CoV-2 in the United States—the first drug to receive that status. The EU and U.S. decisions pave the way for Gilead’s drug into two major markets, both with soaring COVID-19 cases.

But both decisions baffled scientists who have closely watched the clinical trials of remdesivir unfold over the past 6 months—and who have many questions about remdesivir’s worth.

[On] 15 October—in this month’s decidedly unfavorable news for Gilead— the fourth and largest controlled study delivered what some believed was a coup de grâce: The World Health Organization’s (WHO’s) Solidarity trial showed that remdesivir does not reduce mortality or the time COVID-19 patients take to recover.

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The bottom line from the trials so far is there simply isn’t enough evidence that remdesivir works, says [infectious disease researcher] Jason Pogue… Pogue believes FDA made a mistake and, unless more data emerge, EMA should not give the drug full approval. “There are more questions than answers about the efficacy of remdesivir in hospitalized patients,” he says.

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