FDA Issues Emergency Approval For Coronavirus Treatment Drug
President Donald Trump and the Food and Drug Administration announced Friday that it has approved the experimental drug remdesivir for treating coronavirus patients who require hospitalization.
The drug is administered intravenously once a day for up to 10 days and is believed to help patients recover faster.
Its manufacturer, Gilead Sciences, plans to donate 1.1 million vials of the drug and will work with the federal government to distribute it, Gilead CEO Daniel O’Day said at the White House on Friday.
Dr. Anthony Fauci, the nation’s leading official on infectious diseases, had touted an international study of more than 1,000 people earlier this week that supported the drug’s use. An independent data monitoring board that works with the National Institute of Allergy and Infectious Diseases, which Fauci leads, determined that the drug was effective.
“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Fauci said from the White House on Wednesday.
The randomized, controlled study supporting remdesivir’s effects was released the same day. Beginning in late February, 1,063 patients with advanced COVID-19 in 22 countries were given either the drug or a placebo. The placebo patients recovered after 15 days on average, while the group given the new drug recovered in 11 days on average ― a 31% difference.
The mortality rate for the group given remdesivir was also lower than for the placebo group.
The study still requires peer review, and its data differs from certain other studies that produced disappointing results with remdesivir, meaning that the drug might not be so helpful after all.
But some researchers are optimistic.
“This is really quite important for a number of reasons,” Fauci said. “Although a 31% improvement doesn’t seem like a knockout, 100%, it is a very important proof of concept. What it has proven is that a drug can beat this virus.”
Fauci drew...
