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

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."
Subscribe to The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.

Sign up for The Week's Free Newsletters
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
Sign up for Today's Best Articles in your inbox
A free daily email with the biggest news stories of the day – and the best features from TheWeek.com
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.
-
Why some people remember dreams and others don't
Under The Radar Age, attitude and weather all play a part in dream recall
By Chas Newkey-Burden, The Week UK Published
-
The Week contest: Hotel seal
Puzzles and Quizzes
By The Week US Published
-
New FBI Director Kash Patel could profit heavily from foreign interests
The Explainer Patel holds more than $1 million in Chinese fashion company Shein
By Justin Klawans, The Week US Published
-
Ozempic can curb alcohol cravings, study finds
Speed read Weight loss drugs like Ozempic and Wegovy may also be helpful in limiting alcohol consumption
By Peter Weber, The Week US Published
-
New form of H5N1 bird flu found in US dairy cows
Speed Read This new form of bird flu is different from the version that spread through herds in the last year
By Peter Weber, The Week US Published
-
Microplastics accumulating in human brains, study finds
Speed Read The amount of tiny plastic particles found in human brains increased dramatically from 2016 to 2024
By Peter Weber, The Week US Published
-
FDA approves painkiller said to thwart addiction
Speed Read Suzetrigine, being sold as Journavx, is the first new pharmaceutical pain treatment approved by the FDA in 20 years
By Rafi Schwartz, The Week US Published
-
Study finds possible alternative abortion pill
Speed Read An emergency contraception (morning-after) pill called Ella could be an alternative to mifepristone for abortions
By Peter Weber, The Week US Published
-
California declares bird flu emergency
Speed Read The emergency came hours after the nation's first person with severe bird flu infection was hospitalized
By Rafi Schwartz, The Week US Published
-
Bird flu one mutuation from human threat, study finds
Speed Read A Scripps Research Institute study found one genetic tweak of the virus could enable its spread among people
By Peter Weber, The Week US Published
-
Dark chocolate tied to lower diabetes risk
Speed Read The findings were based on the diets of about 192,000 US adults over 34 years
By Peter Weber, The Week US Published