US health authorities on Thursday approved the first drug to treat Covid-19: remdesivir, an antiviral that is administered intravenously to hospitalized patients.
The drug, which California-based Gilead Sciences Inc. calls Veklury, cut recovery time from 15 to 10 days on average in a large-scale study led by the National Institutes of Health.
It had been licensed for use in emergencies since the spring, and has now become the first drug to gain full approval from the Food and Drug Administration (FDA) to treat Covid-19. .
Veklury has been approved for people who are at least 12 years old, weigh at least 88 pounds, and are hospitalized due to a coronavirus infection. For patients under 12 years of age, the FDA will allow the drug to be applied in specific cases, based on its prior authorization for emergency use.
It works by inhibiting a substance that the virus uses to make copies of itself.
Certain kidney and liver tests are required before starting treatment. And the label warns that it should not be used in conjunction with the malaria drug hydroxychloroquine, because that can reduce its effectiveness.
“We now have enough knowledge and a growing set of tools to help fight Covid-19,” said Dr. Merdad Parsey, Gilead’s chief medical officer, in a statement.
The drug is approved or has temporary authorization in about 50 countries, he said.
Its price has been controversial, since no studies have shown that it improves the chances of survival. Last week, a large study led by the World Health Organization concluded that the drug did not help hospitalized patients with Covid-19, but that study did not include a placebo group and was less rigorous than previous studies that found a benefit.
Gilead charges $ 2,340 for typical treatment for people covered by government health insurance programs in the United States and other developed countries and $ 3,120 for patients with private insurance. How much patients pay on their own depends on insurance, income, and other factors.
So far, only steroids like dexamethasone have been shown to reduce the risk of death from Covid-19. The FDA has also given clearance for emergency use of survivor blood plasma, and two companies are seeking similar clearance for experimental antibody drugs.