October 23, 2020
Remdesivir – the experimental drug that has been used to treat hospitalized coronavirus patients since the early months of the pandemic – has become the first COVID-19 treatment approved by the U.S. Food and Drug Administration.
The announcement Thursday came on the heels of a National Institutes of Health study that found remdesivir shortened recovery time from 15 to 10 days. Two other clinical trials also added evidence to its effectiveness.
The antiviral medication, branded Veklury, was developed by Gilead Sciences Inc, a biopharmaceutical company based in California.
In May, the FDA issued an emergency use authorization allowing remdesivir to be used to treat severely-ill, hospitalized COVID-19 patients. Pennsylvania hospitals have had access to the drug since then. The EUA was later expanded to include all hospitalized COVID-19 patients.
The FDA only grants formal approval once there is substantial evidence that a drug is safe and effective for its intended use.
"The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency," FDA Commissioner Dr. Stephen M. Hahn said in a statement. "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."
The FDA approved remdesivir to be used on hospitalized COVID-19 patients age 12 and older and weighing at least 88 pounds. This is a more specific age demographic than those permitted to receive the drug under the EUA. That's because pediatric trials are still underway.
Remdesivir was among the treatments President Donald Trump received after he was hospitalized with COVID-19 earlier this month. He was treated with a five-day course of the drug.
The drug, which originally was developed as a treatment for Ebola and hepatitis C, has received temporary or official approval in 50 countries.
Though the drug quickens recovery time, it has not been shown to prevent death from COVID-19, according to a study conducted by the World Health Organization that involved more than 11,000 patients from 30 countries.
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