U.S. FDA approves antiviral drug remdesivir to treat COVID-19

Remdesivir had been authorized for use on an emergency basis since spring in the U.S., and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19.

Drug, which has been approved by Health Canada, is the 1st approved to treat COVID-19 patients in the U.S.

Remdesivir has been approved by U.S. health authorities for use in COVID-19 patients needing hospitalization. Health Canada already approved the drug in July for patients hospitalized with severe COVID-19 symptoms. (Ulrich Perrey/Reuters)

U.S. regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given through an IV for patients needing hospitalization.

The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.

It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. U.S. President Donald Trump received it when he was sickened earlier this month.

Veklury is approved for people at least 12 years old and weighing at least 40 kilograms who need hospitalization for their coronavirus infection. For patients younger than 12, the FDA will still allow the drug's use in certain cases under its previous emergency authorization.

The drug works by inhibiting a substance the virus uses to make copies of itself. Certain tests are required before starting patients on it. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.

"We now have enough knowledge and a growing set of tools to help fight COVID-19," Gilead's chief medical officer, Dr. Merdad Parsey, said in a statement.

The drug is either approved or has temporary authorization in about 50 countries, he noted.

High costs 

Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit.

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

Only one treatment — steroids such as dexamethasone — has been shown so far 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.

On July 27, Health Canada approved the use of remdesivir to treat COVID-19 in adults and youth 12 years and older with pneumonia requiring supplemental oxygen. The drug was also the first one authorized to treat patients in Canada with severe symptoms who have been hospitalized. 

There are some conditions for the manufacturer for its use in Canada, which Health Canada states is to ensure the "continued safety" of the drug. These conditions include submitting post-market safety monitoring reports and data from ongoing clinical trials.

With files from CBC News

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