(SOUNDBITE) (English) U.S. PRESIDENT DONALD TRUMP SAYING:
"I'm pleased to announce that Gilead now has an EUA (Emergency Use Authorization) from the FDA (Food and Drug Administration) for remdsevir."
The U.S. Food and Drug Administration on Friday granted authorization to Gilead Sciences for emergency use of its experimental antiviral drug remdesivir to treat patients with severe COVID-19 who require oxygen.
During a meeting at the Oval Office, Gilead CEO Daniel O'Day called the move an important first step to helping patients recover:
(SOUNDBITE) (English) GILEAD SCIENCES CEO DANIEL O'DAY SAYING:
"And we want to make sure nothing gets in the way of these patients getting the medicine. So, we made a decision to donate about 1.5 million vials of remdesivir. ...We'll be working with the government to determine how best to distribute that within the United States.”
Gilead on Wednesday said the drug - which previously failed as a treatment for Ebola - had helped improve outcomes for patients with COVID-19.
The company provided data suggesting it worked better when given earlier in the course of infection.
But an abstract released inadvertently by the World Health Organization last week said remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream.
The drugmaker said the findings were inconclusive because the study was terminated early.
Vice President Mike Pence said the 1.5 million vials would start being distributed to hospitals on Monday.