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.
-
Today's political cartoons - December 22, 2024
Cartoons Sunday's cartoons - the long and short of it, trigger finger, and more
By The Week US Published
-
5 hilariously spirited cartoons about the spirit of Christmas
Cartoons Artists take on excuses, pardons, and more
By The Week US Published
-
Inside the house of Assad
The Explainer Bashar al-Assad and his father, Hafez, ruled Syria for more than half a century but how did one family achieve and maintain power?
By The Week UK 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
-
ACA opens 2025 enrollment, enters 2024 race
Speed Read Mike Johnson promises big changes to the Affordable Care Act if Trump wins the election
By Peter Weber, The Week US Published
-
McDonald's sued over E. coli linked to burger
Speed Read The outbreak has sickened at least 49 people in 10 states and left one dead
By Rafi Schwartz, The Week US Published
-
Texas dairy worker gets bird flu from infected cow
Speed Read The virus has been spreading among cattle in Texas, Kansas, Michigan and New Mexico
By Peter Weber, The Week US Published
-
Dengue hits the Americas hard and early
Speed Read Puerto Rico has declared an epidemic as dengue cases surge
By Peter Weber, The Week US Published
-
US bans final type of asbestos
Speed Read Exposure to asbestos causes about 40,000 deaths in the U.S. each year
By Peter Weber, The Week US Published