Report: FDA to authorize Remdesivir for emergency use
OAN Newsroom
UPDATED 6:45 PM PT — Wednesday, April 29, 2020
The Food and Drug Administration will reportedly authorize the
experimental drug Remdesivir for emergency use. According to a new report, the FDA will give the green light for hospitals to treat patients in severe condition.“The agency has been engaged in sustained and ongoing discussions with Gilead Sciences about making Remdesivir available to patients as quickly as possible as appropriate,” stated one FDA spokesperson.
President Trump and the White House task force are optimistic over new data, which showed trials of the experimental drug yielding positive results in the fight against the coronavirus.
“I thought Tony (Fauci) explained it
really well. It’s a beginning, it means you build on it. I love that as a
building block, you know, just as a building block. But certainly, it’s
a very positive event.”
– Donald Trump, 45th President of the United States
The maker of the drug, Gilead Sciences, released its initial findings
Wednesday, which showed improvements among 50 percent of the 397
patients infected with the virus over a five-day period. However, the
study was not tested against a control group who took a placebo.Despite this, over half of the patients in the trial were released from the hospital in about two weeks.
Dr. Anthony Fauci has said the National Institute of Allergy and Infectious Diseases, which he oversees, released their study of the drug. Their research showed Remdesivir has a “clear cut, significant positive effect in diminishing the time to recovery.”
“This is really quite important for a
number of reasons. If you look at the time to recovery being shorter in
the Remdesivir arm, it was 11 days compared to 15 days… Although a 31
percent improvement doesn’t seem like a knock out, 100 percent it is a
very important proof of concept. What it has proven is a drug can block
this virus.”
– Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases
The health institute’s trials were the most comprehensive to date, as it was double blinded and placebo controlled.Fauci also revealed the drug blocks an enzyme that the virus uses and noted the rate of fatalities was much lower in the institute’s study.
“The reason why we are making the announcement now is something I believe people don’t fully appreciate,” he added. “Whenever you have clear cut evidence that a drug works, you have an ethical obligation to immediately let the people who are in the placebo group know, so they can have access and all of the other trials in place now have a new standard of care.”
Dr. Fauci remained cautiously hopeful about the new data, saying there still needs to be more studies done to improve the effectiveness of Remdesivir.
“We think it’s really opening the door to the fact that we now have the capability of treating,” stated the doctor. “I can guarantee you, as more people, more companies, more investigators get involved, it’s going to get better and better.”
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