The U.S. Food and Drug Administration has approved the drug remdesivir to treat the COVID-19 virus, the first drug to gain that ranking.
The agency approved the drug for use in adults and children at least 12 years old. It must be administered in a hospital or health care setting, the FDA statement said.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Dr. Stephen Hahn.
“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,” Hahn said.
Remdesivir was one of the drugs given to President Donald Trump after he was diagnosed with the virus and hospitalized earlier this month.
The drug, whose brand name is Veklury, has been used to treat patients under an Emergency Use Authorization that was issued on May 1. It is produced by Gilead Sciences, Inc.
A World Health Organization-sponsored global study found that remdesivir was not effective in helping patients survive or even recover faster, compared to a U.S. study that found the drug shortened by a third the recovery time for some patients.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead CEO Daniel O’Day said in a statement. “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.”
Remdesivir is approved for use in approximately 50 countries worldwide, according to the company. It is administered intravenously over a five-day period.
The drug costs $2,340 for a five-day treatment course for people covered by government health programs. For those with private insurance, the drug is $3,120.
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