The Food and Drug Administration approved remdesivir to treat Covid-19 on Thursday, making it the first and only drug so far to have received federal approval for the coronavirus.
The drug, made by Gilead Sciences, had been granted emergency use authorization by the FDA in May. But to get full FDA approval, a drugmaker must submit additional evidence to support safety and efficacy.
Remdesivir is now approved for patients over age 12 who are hospitalized with Covid-19. It is given intravenously, generally for five days.
An emergency use authorization meant physicians could give the drug to hospitalized Covid-19 patients, but they had to go through an extensive consent process with patients’ families before doing so.
Thursday’s approval is expected to streamline and ease the process for doctors.
Daniel O’Day, Gilead’s CEO, said in a statement that “it is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as Covid-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.”
Gilead will sell the drug under the brand name Veklury.
Remdesivir is an antiviral drug, meaning it is thought to work by lowering the amount of virus in the body. The drug has been shown to do so in laboratory studies and animals; however, it has not been proven to work that way in humans.
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A National Institutes of Health-funded clinical trial found that the drug reduced the length of hospital stays among patients with moderate illness by about four days, from 15 to 11 days.
Remdesivir has not been shown to significantly lower the mortality rate of Covid-19. And recently, the World Health Organization released preliminary data showing that the drug did not benefit the very sickest Covid-19 patients. The finding did not surprise many infectious disease experts, who say antivirals such as remdesivir usually work best if they are administered early.
President Donald Trump received a course of the drug when he was treated for Covid-19 this month.