President Donald Trump announced Friday that the Food and Drug Administration had granted an emergency authorization for the use of the experimental medication remdesivir as a treatment against coronavirus.
In recent clinical trials the drug showed promise in preventing new infections and shortening the recovery time for hospitalized coronavirus patients.
Friday’s authorization was widely expected, and the drug will be administered first to those who are the sickest, according to reports.
Friday's approval by the FDA was the first official authorization of its use anywhere in the world. The agency also released a digital fact sheet about the drug.
The drug’s maker, Gilead Sciences, has agreed to donate the first 1 million vials of the drug, Trump said, calling it an important first step toward beating the virus.
Trump made the announcement in the Oval Office alongside Gilead CEO Daniel O’Day.
“We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers,” O’Day said.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, which conducted the trials, has called the quick development of the drug “very important.”
Having a treatment could have a profound effect because health officials say any vaccine typically takes a year or more to develop and bring to market safely.
Previously the FDA authorized the emergency use of malaria drugs chloroquine and hydroxychloroquine to treat the virus, but followed up with warnings against taking the drugs outside a hospital because of its potential to cause heart rhythm problems.
Remdesivir is given through an IV and is designed to interfere with an enzyme that reproduces viral genetic material.
— This is a developing story. Please return to AJC.com for updates.
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