There Is Now an FDA-Approved Treatment for COVID-19

The FDA has extended its first approval (not just emergency clearance) for a drug to treat COVID-19. You’ve probably heard of this medication: the antiviral remdesivir, which has been used in hospitals for the past few months.

What is remdesivir?

Remdesivir, sold under the brand name Veklury, is an antiviral agent. This means that it interferes with the process by which the virus produces itself to a greater extent within human cells. It was previously tested against Ebola and hepatitis C, but never made it to the market. Veklury is manufactured by the pharmaceutical company Gilead, which charges $ 3,120 for a course of treatment for insured patients in the United States.

Remdesivir is one of the treatments President Trump reportedly received when he contracted COVID-19, along with the corticosteroid dexamethasone and an antibody cocktail created by Regeneron.

How well does it work?

It’s a difficult question. In a press release, Gilead points to research showing remdesivir reduced recovery time from 15 days to 10 days, which sounds great.

But other studies have shown less benefit, and some experts are skeptical if this provides anything at all. A recent study by the World Health Organization found that it does not save lives or shorten hospital stays. (The same study found no significant benefits of hydroxychloroquine.)

In its statement, the FDA cites three trials, including one that improved in five days . Trials to determine how well remdesivir works are still ongoing, even after its approval.

What does approval mean?

According to the FDA, full approval requires “substantial evidence of efficacy and demonstration of safety for the intended use,” including an assessment of how the benefits compare to the risks to the population for which it is approved.

Authorization to use the drug in hospitalized patients is permitted and should only be administered in a hospital. It is approved for adults and children 12 years of age and older and weighing at least 40 kg (88 lb).

Remdesivir was previously available under an Emergency Use Authorization or EUA, which had less stringent requirements. (Hydroxychloroquine was available under the EUA earlier this year, but EUA was withdrawn after further test results showed it did not appear to be effective.) Initially, in May, EUA for remdesivir was used only for critically ill patients. Then, in August, EUA was expanded to include all hospitalized patients. EUA was revised again along with approval; EUA now allows doctors to prescribe it to children outside the approved population.

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