Despite Conflicting Evidence, FDA Approves Covid-19 Drug Remdesivir

On Friday, the U.S. Food and Drug Administration (FDA) gave its first official stamp of approval to a Covid-19 drug — remdesivir. The repurposed antiviral, now also known by the generic name of Veklury, was granted emergency use authorization (EUA) in May and has been administered intravenously to hospitalized Covid-19 patients ever since.

The conclusion of a study sponsored by the National Institutes of Health (NIH), which published its final report two weeks ago, appears to be the main reason regulators moved forward with approval. But like the preliminary research that paved the way for the drug’s EUA, the NIH study shows that remdesivir was at best only moderately effective in reducing the suffering and death of those who took it. Not too shabby, but not particularly heartening either.

Just last week, newly published interim results from the largest clinical study of remdesivir (and three other drugs) to date, the World Health Organization’s (WHO) Solidarity trial, cast some doubt on even these modest benefits. Involving more than 11,300 people across 30 countries, the study found that Covid-19 patients prescribed remdesivir weren’t any likelier to survive than those who weren’t. Neither did they have a shorter or less painful hospital stay.

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Originally published on Forbes (October 26, 2020)

© William A. Haseltine, PhD. All Rights Reserved.