The Food and Drug Administration (FDA) approved the antiviral drug remdesivir from the company Gilead Sciences on Thursday as a treatment for COVID-19.
Although
the FDA had already authorized the emergency use of remdesivir in May for hospitalized patients, it is the first drug to receive formal authorization
from the authorities in the United States to treat the coronavirus.
The antiviral, which the Gilead company has called Veklury, is given intravenously and has been shown to reduce recovery time by five days on average, according to a large study led by the National Institutes of Health.
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Veklury is approved for people 12 years and older who weigh at least 88 pounds (40 kilos) and who require hospitalization for their coronavirus infection.
The FDA will allow the use of the drug for patients under 12 years of age in certain cases, with its prior emergency authorization.
The drug works by inhibiting a substance that the virus uses to make copies of itself.
Before patients start using it, some tests should be done.
And the label warns against its simultaneous use with hydroxychloroquine, an antimalarial drug, because it can inhibit its effectiveness.
"We now have enough knowledge and a growing set of tools to help us fight COVID-19," Gilead Medical Director Dr. Merdad Parsey said in a statement.
The drug has been approved or temporarily licensed in about 50 countries, Parsey noted.
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President Donald Trump received remdesivir as part of the cocktail of drugs he was given earlier this month when he was diagnosed with COVID-19.
Gilead charges $ 2,340 for full treatment to people covered by government health programs in the United States and other developed countries and charges $ 3,120 for patients with private insurance.
How much patients pay out of pocket depends on insurance, income, and other factors.
So far, only one treatment, steroids like dexamethasone, has been shown to reduce the risk of death from COVID-19.
The FDA has also granted an emergency authorization to use the blood of survivors and two companies are seeking a similar authorization for experimental antibody drugs.
