Remdesivir Becomes First Fully-Approved FDA COVID-19 Treatment
The Food and Drug Administration has approved remdesivir as a treatment for the coronavirus.
The move comes less than a week after the World Health Organization published results of a large study that suggested remdesivir did not help hospitalized COVID-19 patients.
A previous study by the U.S. National Institutes of Health found the antiviral drug shortened recovery time by five days, on average. That led to the drug getting emergency use approval in the U.S, as well as many other countries.
The FDA’s decision on Thursday formally approves remdesivir as a treatment option, and makes it the first fully-approved treatment in the U.S.
None of the studies have found that the drug can improve survival rates.
Remdesivir is one of the treatments President Donald Trump received when he contracted COVID-19 earlier this month. It is usually given over five days and works by helping to stop the replication of COVID-19 in the body.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
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