The U.S. Food and Drug Administration has officially approved remdesivir as a treatment for coronavirus, drug manufacturer Gilead Sciences announced Thursday.
The Ebola drug was already being used to treat patients under an emergency-use authorization issued in May, but the latest FDA action makes it “the first and only approved COVID-19 treatment” in the United States, according to the company.
The antiviral drug has been found to reduce recovery time by an average of five days among those who are sick enough to be hospitalized. Also known by the brand name Veklury, the drug can fast-track recovery by blocking an enzyme that COVID-19 uses to spread inside the body, research has shown.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead CEO and Chairman 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,” he said.
Dr. Anthony Fauci, the federal government’s leading expert on infectious diseases, previously said the drug has a “clear-cut, significant, positive effect in diminishing the time to recovery.”
“It’s the first step in what we project will be better and better drugs coming along,” he told NBC News in an April interview.
But a recent study by the World Health Organization suggests the treatment is far from perfect. The massive study of patients across 30 countries found that remdesivir, which was originally created to treat Ebola, did not improve coronavirus survival rates and did not help patients get out of the hospital more quickly.
Since Gilead received emergency authorization to sell remdesivir in the U.S., the drug has been used to treat hospitalized patients as young as 12 years old.
A typical treatment plan costs U.S. hospitals at least $3,120 for per patient with private insurance. The company charges the U.S. government, which funds programs like Medicaid, a discounted rate of $2,340 for the shortest treatment course.
The California-based drugmaker said Thursday’s approval was the result of three successful clinical trials, which resulted in “clinically meaningful improvements” for patients with severe symptoms.
“Based on the strength of these data, Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients,” the company said in a news release.
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