FDA grants emergency use of remdesivir for COVID-19
- 4 years ago
미국 FDA, 코로나19 치료제로 '렘데시비르' 긴급사용 승인
The total number of confirmed COVID-19 cases around the world has so far reached over three million.
And now, the FDA has authorized the antiviral drug Remdesivir, which appears to be the most promising treatment so far to tackle the virus.
Kim Sung-min reports. The U.S. Food and Drug Administration has granted emergency use authorization of the experimental antiviral drug remdesivir for treating hospitalized COVID-19 patients on Friday.
The FDA decision greatly waives formal safety standards, only requiring the drug's potential benefits to be greater than the risks.
The approval came after the drug produced by Gilead Sciences was shown to be effective in treating the coronavirus.
In a study conducted on more than one-thousand patients, the drug appeared to have shortened the recovery time by 31%, which is around 4 days on average.
With the emergency authorization, remdesivir will be allowed for COVID-19 patients or those suspected to be infected...whose condition is considered "severe."
President Donald Trump announced the decision on Friday alongside the CEO of Gilead Sciences, Daniel O'Day.
"I'm pleased to announce that Gilead now has an EUA from the FDA for Remdsevir...And it's something, I spoke with Dr. Kahn, Dr. Fauci. I spoke with Deborah about it and it's really a very promising situation."
Daniel O'Day added that the company is donating a significant amount of the drug to help people in need.
"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."
Following the news, an official for South Korea's Centers for Disease Control and Prevention said the center is currently discussing with related authories and departments the drug's clinical test results... as well as reviewing preferential treatment for import in case it is necessary.
KIM Sung-min, Arirang News
The total number of confirmed COVID-19 cases around the world has so far reached over three million.
And now, the FDA has authorized the antiviral drug Remdesivir, which appears to be the most promising treatment so far to tackle the virus.
Kim Sung-min reports. The U.S. Food and Drug Administration has granted emergency use authorization of the experimental antiviral drug remdesivir for treating hospitalized COVID-19 patients on Friday.
The FDA decision greatly waives formal safety standards, only requiring the drug's potential benefits to be greater than the risks.
The approval came after the drug produced by Gilead Sciences was shown to be effective in treating the coronavirus.
In a study conducted on more than one-thousand patients, the drug appeared to have shortened the recovery time by 31%, which is around 4 days on average.
With the emergency authorization, remdesivir will be allowed for COVID-19 patients or those suspected to be infected...whose condition is considered "severe."
President Donald Trump announced the decision on Friday alongside the CEO of Gilead Sciences, Daniel O'Day.
"I'm pleased to announce that Gilead now has an EUA from the FDA for Remdsevir...And it's something, I spoke with Dr. Kahn, Dr. Fauci. I spoke with Deborah about it and it's really a very promising situation."
Daniel O'Day added that the company is donating a significant amount of the drug to help people in need.
"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."
Following the news, an official for South Korea's Centers for Disease Control and Prevention said the center is currently discussing with related authories and departments the drug's clinical test results... as well as reviewing preferential treatment for import in case it is necessary.
KIM Sung-min, Arirang News