FDA issues emergency authorization to use remdesivir as COVID-19 treatment
Remdesivir is given to coronavirus patients who are “hospitalized with a serious illness”.
Ulrich Perrey / POOL / AFP
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The United States Food and Drug Administration has issued an emergency approval for the drug Remdesivir to be used in cases of COVID-19 where patients “are hospitalized with serious illness”. The FDA announced on Friday afternoon that while there is limited information about the safety or efficacy of the experimental drug, a clinical trial earlier this week showed a faster recovery time in some patients.
Remdesivir, an experimental antiviral drug from biotech company Gilead Sciences, is injected into suspected or confirmed coronavirus patients by healthcare providers who have low blood oxygen levels, need oxygen therapy, or, like a ventilator, need breathing support.
Minister of Health and Human Services, Alex Azar, called it “a significant step forward in the fight against COVID-19”.
The approval is given only two days later The drug showed a “clearly positive effect” in a US study. The US National Institute of Allergy and Infectious Diseases said Wednesday that preliminary data from a U.S. clinical trial showed that it can help patients recover faster from the coronavirus.
At that time, NIAID director Dr. Anthony Fauci, the first results are “a very important proof of concept because it has been shown that a drug can block this virus”.
The NIAID study involved 1,000 patients who had a 31% faster recovery time and a slightly lower mortality rate. Remdesivir was originally developed to treat Ebola, but was largely unsuccessful in testing. A study from 2017 showed this effective against human corona viruses.
Gilead said that hospitals with intensive care units and hospitals that the federal government decides that they need the drug most urgently will have priority in procuring its limited supply of remdesivir. “Gilead is working with the U.S. government on the logistics of Remdesivir distribution and will provide more information when the company begins shipping the drug,” the company said Friday.
“We will continue to work with partners around the world to increase our range of remdesivir while advancing our ongoing clinical trials to complement our understanding of the drug profile,” said Daniel O’Day, CEO of Gilead Sciences, in a per Declaration sent by email. “We are working to meet the needs of patients, their families, and healthcare professionals around the world with the utmost urgency and responsibility.”
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Coronavirus drug shows “clear” evidence of faster …
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