FDA approves remdesivir to treat COVID-19

The Food and Drug Administration said Thursday in a letter that it has approved remdesivir as a treatment for coronavirus patients.

It had been authorized for use on an emergency basis since spring and now has become the first drug to win full U.S. approval for treating COVID-19.

“The approval … marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster,” Dr. Barry Zingman said in a news release provided by Gilead Sciences, which said the use of the drug is for patients hospitalized with COVID-19.

Earlier this month, a World Health Organization-sponsored global study found remdesivir did not help patients survive or even recover faster, but a U.S. study found the infused drug shortened recovery time for some patients by about a third.

In a large study led by the U.S. National Institutes of Health, the drug cut the time to recovery by five days — from 15 days to 10 on average. President Donald Trump received it when he was sickened earlier this month.

Fauci talks about early results in remdesivir study

The drug is for adults and certain children ages 12 and older, depending on their weight. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.

It works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.

Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.

So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs.

CNN contributed to this report.

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