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.
-
Do smartphone bans in schools work?
The Explainer Trials in UK, New Zealand, France and the US found prohibition may be only part of the solution
-
Doom: The Dark Ages – an 'exhilarating' prequel
The Week Recommends Legendary shooter adds new combat options from timed parries to melee attacks and a 'particularly satisfying' shield charge
-
7 US cities to explore on a microtrip
The Week Recommends Not enough vacation days? No problem.
-
Trump seeks to cut drug prices via executive order
speed read The president's order tells pharmaceutical companies to lower prescription drug prices, but it will likely be thrown out by the courts
-
RFK Jr. visits Texas as 2nd child dies from measles
Speed Read An outbreak of the vaccine-preventable disease continues to grow following a decade of no recorded US measles deaths
-
Shingles vaccine cuts dementia risk, study finds
Speed Read Getting vaccinated appears to significantly reduce the chances of developing Alzheimer's and other forms of dementia
-
Measles outbreak spreads, as does RFK Jr.'s influence
Speed Read The outbreak centered in Texas has grown to at least three states and Health Secretary Robert F. Kennedy Jr. is promoting unproven treatments
-
RFK Jr. offers alternative remedies as measles spreads
Speed Read Health secretary Robert F. Kennedy Jr. makes unsupported claims about containing the spread as vaccine skepticism grows
-
Texas outbreak brings 1st US measles death since 2015
Speed read The outbreak is concentrated in a 'close-knit, undervaccinated' Mennonite community in rural Gaines County
-
Mystery illness spreading in Congo rapidly kills dozens
Speed Read The World Health Organization said 53 people have died in an outbreak that originated in a village where three children ate a bat carcass
-
Ozempic can curb alcohol cravings, study finds
Speed read Weight loss drugs like Ozempic and Wegovy may also be helpful in limiting alcohol consumption