FDA reportedly plans to authorize emergency use of largely untested drug to treat coronavirus

FDA Commissioner Dr. Stephen Hahn.
(Image credit: Drew Angerer/Getty Images)

The Food and Drug Administration will authorize the emergency use of the antiviral remdesivir on COVID-19 patients as soon as Wednesday, a senior administration official told The New York Times. Pharmaceutical company Gilead Sciences revealed promising study results involving remdesivir on Wednesday, but the FDA's reported move would still sidestep the usual testing required to authorize a drug's usage.

Gilead said Wednesday that its own trial, as well one overseen by the National Institute of Allergy and Infectious Diseases, met its goals. Of the study's 397 severe COVID-19 patients, at least 50 percent of patients treated with a 5-day dosage of remdesivir improved and more than half were discharged from the hospital within two weeks. The overall mortality rate of the study was 7 percent, and relatively few patients developed bad side effects. But the study wasn't evaluated against a control group, and it's unclear if those recoveries were natural or if remdesivir actually had something to do with them. Hard data from the study also hasn't been released yet.

Anecdotal reports, including two published in The New England Journal of Medicine, provided more credibility for remdesivir in the coronavirus fight. But they also didn't compared the drug against a placebo. A study published in The Lancet concluded remdesivir was "safe and adequately tolerated" but "did not provide significant benefits over placebo."

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Kathryn Krawczyk

Kathryn is a graduate of Syracuse University, with degrees in magazine journalism and information technology, along with hours to earn another degree after working at SU's independent paper The Daily Orange. She's currently recovering from a horse addiction while living in New York City, and likes to share her extremely dry sense of humor on Twitter.